Clinical Trial Results:
Neurophysiology of Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Dyslexia: Functional Magnetic Resonance Imaging (fMRI) Measures of Brain Activation During Attention and Reading Tasks Pre- and Post-Atomoxetine Treatment
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Summary
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EudraCT number |
2019-000419-98 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
01 Jul 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Aug 2024
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First version publication date |
16 Aug 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B4Z-US-LYEI
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00716274 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Trial Number: 12212 | ||
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Sponsors
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Sponsor organisation name |
Eli Lilly and Company
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Sponsor organisation address |
Lilly Corporate Center, Indianapolis, IN, United States, 46285
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Public contact |
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
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Scientific contact |
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jul 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jul 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 110
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Worldwide total number of subjects |
110
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
64
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Adolescents (12-17 years) |
46
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
No Text Available | ||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug. | ||||||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Study Period II (16-Weeks)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Atomoxetine | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III). | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
LY139603
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
placebo was administered orally, daily, for 16 weeks
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Arm title
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Healthy Participants | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 2
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Period 2 title |
Study Period III (16-Weeks)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ATX/ATX | ||||||||||||||||||||||||||||||||||||||||
Arm description |
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
LY139603
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
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Arm title
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ATX/PLA | ||||||||||||||||||||||||||||||||||||||||
Arm description |
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
LY139603
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was administered orally, daily, for 16 weeks
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Arm title
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PLA/ATX | ||||||||||||||||||||||||||||||||||||||||
Arm description |
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
placebo was administered orally, daily, for 16 weeks
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Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
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Other name |
LY139603
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks
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Arm title
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Healthy Participants | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Atomoxetine
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Reporting group description |
Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Healthy Participants
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Reporting group description |
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atomoxetine
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Reporting group description |
Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III). | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | ||
Reporting group title |
Healthy Participants
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Reporting group description |
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. | ||
Reporting group title |
ATX/ATX
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Reporting group description |
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||
Reporting group title |
ATX/PLA
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Reporting group description |
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||
Reporting group title |
PLA/ATX
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Reporting group description |
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||
Reporting group title |
Healthy Participants
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Reporting group description |
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. | ||
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End point title |
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) [1] [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category). Analysis Population Description (APD): All participants who received study drug, had Dyslexia Alone and had fMRI data.
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End point type |
Primary
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End point timeframe |
Baseline, 16 Weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
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| Notes [3] - Semantic-category, Pseudoword Rhyming: n = 13 [4] - Semantic-category: n = 10 Pseudoword Rhyming: n = 09 |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) [5] [6] | ||||||||||||
End point description |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks). APD: Stroop Tasks data were not collected.
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End point type |
Primary
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End point timeframe |
Baseline, 16 Weeks
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
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| Notes [7] - Stroop Tasks data were not collected. [8] - Stroop Tasks data were not collected. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) [9] [10] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks). APD: All participants who received study drug, had ADHD or ADHD + Dyslexia and had fMRI data.
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End point type |
Primary
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End point timeframe |
Baseline, 16 Weeks
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
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| Notes [11] - ADHD+Dyslexia, Semantic-category (SC): n=10, Pseudoword Rhyming (PR): n=9; ADHD Only, SC, PR: n=11 [12] - ADHD+Dyslexia, Semantic-category (SC): n=12, Pseudoword Rhyming (PR): n=11; ADHD Only, SC, PR: n=8 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) [13] [14] | ||||||||||||
End point description |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks). Stroop Tasks data were not collected.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| Notes [15] - Stroop Tasks data were not collected. [16] - Stroop Tasks data were not collected. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia [17] [18] | ||||||||||||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
||||||||||||||||||
| Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants with Dyslexia Alone [19] [20] | ||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard &Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths & weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, & 20. Standard score scale is a mean (M) of 100 & a standard deviation (SD) of 15. WJ III ACH has extended standard scores which is a greater range of standard scores. Each individual test scores range from 0 to over 200 where 69 & below is very low & 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistical analyses was planned for this endpoint. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants with Dyslexia Alone [21] | ||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard score scale is a mean (M) of 100 & a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, & structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant’s word identification skills. It is the average (arithmetic mean) of tests 1 & 13. Scores for each individual test range from 0 to over 200 where 69 & below is very low and 131 & above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least 1 dose of study drug & had evaluable baseline and post baseline WJ III measurements.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia [22] | ||||||||||||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, “ADD possible but not likely”. 40-54 equate to, “ADD probable but not certain”. 55-120 equate to, “ADD highly probable”. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||||||||
| Notes [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone [23] | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who had a WJ III baseline and post-baseline measurement.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia [24] | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who had a baseline and post-baseline WJ III measurement.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone [25] | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. All randomized participants who had a baseline and post-baseline WJ III measurement.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants with Dyslexia Alone [26] | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||
| Notes [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Score in Participants with ADHD + Dyslexia [27] | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||
| Notes [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Score in Participants with ADHD Alone [28] | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||
| Notes [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants with Dyslexia Alone [29] | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||||||||
| Notes [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD + Dyslexia [30] | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||||||||
| Notes [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD Alone [31] | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
|||||||||||||||||||||||||||
| Notes [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants with Dyslexia Alone [32] | ||||||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in TOWRE Total Score in Participants with ADHD or ADHD + Dyslexia [33] | ||||||||||||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||||||||
| Notes [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants with Dyslexia Alone [34] | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint WMTB-C in Participants with ADHD + Dyslexia [35] | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint WMTB-C in Participants with ADHD Alone [36] | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
|||||||||||||||||||||||||||||||||||||||
| Notes [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone [37] | ||||||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint in ADHDRS-IV Total Score in Participants with Dyslexia Alone [38] | ||||||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||
| Notes [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone [39] | ||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia [40] | ||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard tests (1 -12) have broad set of scores. Extended tests (13 -22) have more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, & 20. Standard score scale is a mean (M) of 100 & a SD of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range 0 to over 200 where 69 & below is very low & 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, & baseline score by treatment interaction. APD: All randomized participants who received atomoxetine in both phases & had evaluable baseline, post baseline WJ III measurements. No participants by design were on placebo for both II & III period
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone [41] | ||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. Standard score scale is mean (M) of 100 & SD of 15. WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 & below is very low & 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, baseline score by treatment interaction. APD: All randomized participants who received atomoxetine in both phases & evaluable baseline, post baseline CTOPP measurements. No participants by design were on placebo for study periods II & III.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||
End point title |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone [42] | ||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||
| Notes [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||
End point title |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia [43] | ||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||
| Notes [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||
End point title |
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone [44] | ||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||
| Notes [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with Dyslexia Alone [45] | ||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||
| Notes [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD + Dyslexia [46] | ||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||
| Notes [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD Alone [47] | ||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||
| Notes [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||
End point title |
Change from Baseline to Endpoint in Participants in TOWRE Total Score with Dyslexia Alone [48] | ||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||
| Notes [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint in Participants in TOWRE Total Score with ADHD or ADHD + Dyslexia [49] | ||||||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II & III
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||
| Notes [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Participants in WMTB-C with Dyslexia Alone [50] | ||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Participants in WMTB-C with ADHD + Dyslexia [51] | ||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in Participants in WMTB-C with ADHD Alone [52] | ||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||
End point title |
Change from Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone [53] | ||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||
| Notes [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia [54] | ||||||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||
| Notes [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||
End point title |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone [55] | ||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||
| Notes [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||
End point title |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia [56] | ||||||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. APD: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||
| Notes [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||||||||
End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) | |||||||||||||||
End point description |
For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time. APD: For this outcome measure, there were no data collected beyond 16 weeks.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||
|
||||||||||||||||
| Notes [57] - No data collected beyond 16 weeks [58] - No data collected beyond 16 weeks |
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||
End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) | |||||||||
End point description |
For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time. APD: Stroop Tasks data were not collected.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From Week 16, Up to 32 Weeks
|
|||||||||
|
||||||||||
| Notes [59] - Stroop Tasks data were not collected. [60] - Stroop Tasks data were not collected. |
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||||||||
End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | |||||||||||||||
End point description |
APD: For this outcome measure, there were no data collected beyond 16 weeks
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||
|
||||||||||||||||
| Notes [61] - No data collected beyond 16 weeks [62] - No data collected beyond 16 weeks |
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||
End point title |
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | |||||||||
End point description |
For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time. APD: Stroop Tasks data were not collected.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||
|
||||||||||
| Notes [63] - Stroop Tasks data were not collected. [64] - Stroop Tasks data were not collected. |
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have in-depth diagnostic assessment of academic strength & weakness. Tests administered were 1, 2, 7, 9, 13, 17, & 20. Standard score scale is mean (M) of 100 & standard deviation (SD) of 15. WJ III ACH has standard scores, which is greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 & below is very low & 131 & above is very superior. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baselinescore, age, & baselinescore by treatment interaction. APD: All participants who received atleast 1 dose of study drug & had evaluable baseline, post baseline WJIII measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to 32 Weeks
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have in-depth diagnostic assessment of academic strength & weakness. Tests administered were 1, 2, 7, 9, 13, 17, & 20. Standard score scale is mean (M) of 100 & standard deviation (SD) of 15. WJ III ACH has standard scores, which is greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 & below is very low & 131 & above is very superior. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baselinescore, age, & baselinescore by treatment interaction. APD: All participants who received atleast 1 dose of study drug & had evaluable baseline, post baseline WJIII measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone | |||||||||||||||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has 2 parallel forms (A & B) alternating 2 batteries of tests—Standard & Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have in-depth diagnostic assessment of academic strength & weakness. Tests administered were 1, 2, 7, 9, 13, 17, & 20. Standard score scale is mean (M) of 100 & standard deviation (SD) of 15. WJ III ACH has standard scores, which is greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 & below is very low & 131 & above is very superior. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baselinescore, age, & baselinescore by treatment interaction. APD: All participants who received atleast 1 dose of study drug & had evaluable baseline, post baseline WJIII measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Scores in Participants with Dyslexia Alone | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. Test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Scores in Participants with ADHD + Dyslexia | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. Test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Scores in Participants with ADHD Alone | |||||||||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. Composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||
End point title |
Change from Baseline to Endpoint TOWRE Total Score in Participants with Dyslexia Alone | ||||||||||||
End point description |
TOWRE is a measure of an individual's ability to pronounce printed words accurately & fluently, is appropriate for individuals aged 6 to 24 years old. The TOWRE contains 2 subtests: Sight Word Efficiency (SWE) which assesses no. of real printed words that can be accurately identified within 45 seconds & Phonemic Decoding Efficiency (PDE) which measures the no. of pronounceable printed non-words that can be accurately decoded within 45 seconds. Total standard score ranges from 35-165. Higher scores indicate higher & lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction. APD: All participants who received at least 1 dose of study drug & had evaluable baseline, post baseline TOWRE measurements. Objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in TOWRE Total Score in Participants with ADHD or ADHD + Dyslexia | ||||||||||||||||||
End point description |
TOWRE is a measure of an individual's ability to pronounce printed words accurately & fluently, is appropriate for individuals aged 6 to 24 years old. The TOWRE contains 2 subtests: Sight Word Efficiency (SWE) which assesses no. of real printed words that can be accurately identified within 45 seconds & Phonemic Decoding Efficiency (PDE) which measures the no. of pronounceable printed non-words that can be accurately decoded within 45 seconds. Total standard score ranges from 35-165. Higher scores indicate higher & lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction. APD: All participants who received at least 1 dose of study drug & had evaluable baseline, post baseline TOWRE measurements. Objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with Dyslexia Alone | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. Test has 2 parallel forms, Form A & B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories & 5 multiple-choice comprehension questions for each story. GORT-4 yields scores: rate, accuracy, fluency, comprehension, & overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD+ Dyslexia | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. Test has 2 parallel forms, Form A & B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories & 5 multiple-choice comprehension questions for each story. GORT-4 yields scores: rate, accuracy, fluency, comprehension, & overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Participants with ADHD Alone | |||||||||||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has 2 parallel forms, Form A & B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All participants who received at least
1 dose of study drug & had evaluable baseline, post baseline GORT-4 measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in WMTB-C in Participants with Dyslexia Alone | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal info for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); & visuo-spatial sketchpad (VSSP) which holds info in visual & spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least 1 dose of study drug & had baseline & post baseline WMTB-C measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX are given.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint WMTB-C in Participants with ADHD + Dyslexia | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal info for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds info in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received at least 1 dose of study drug & had baseline, post baseline WMTB-C measurements. Objectives forthis portion of trial centered around participants already exposed to ATX for 16 weeks & therefore no data for PLA/ATX are given
|
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End point type |
Secondary
|
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End point timeframe |
From Week 16, Up to Week 32
|
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
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End point title |
Change from Baseline to Endpoint WMTB-C in Participants with ADHD Alone | |||||||||||||||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); & visuo-spatial sketchpad (VSSP) which holds info in visual & spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. APD: All randomized participants who received atleast 1 dose of study drug & had baseline, post baseline WMTB-C measurements. Objectives for this portion of trial centered around participants already exposed to ATX for 16weeks & thereforeno data for PLA/ATX are given
|
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End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
|
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End point title |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | ||||||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, & activating to work 2) Focusing, sustaining and shifting attention to tasks 3) Regulating alertness, sustaining effort, & processing speed; 4) Managing frustration & modulating emotions; 5) Utilizing working memory & accessing recall (Brown 2001). Scores range from 0-120. Higher score, more severe ADD. Scores of 0-39 = "ADD possible but not likely". Scores of 40-54 = "ADD probable but not certain". Scores of 55-120 = "ADD highly probable". LS mean calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, & baseline-by-visit interaction. APD: All randomized participants who received atleast 1 dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of trial centered around participants already exposed to ATX for 16 weeks, so no data for PLA/ATX ae given
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
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|
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| No statistical analyses for this end point | |||||||||||||
|
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End point title |
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | ||||||||||||||||||
End point description |
BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, & activating to work; 2) Focusing, sustaining & shifting attention to tasks; 3) Regulating alertness, sustaining effort, & processing speed; 4) Managing frustration & modulating emotions; 5) Utilizing working memory & accessing recall (Brown 2001). Scores range from 0-120. The higher score, more severe ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using REML-based, MMRM analysis which includes treatment, baseline, visit, treatmentbyvisit interaction, & baselinebyvisit interaction. APD: All randomized participants who received atleast 1dose ofdrug & had baseline, postbaseline BADD-A measurements. Objectives for this portion of trial centered around participants already exposed to ATX for16weeks & no data for PLA/ATX are given
|
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End point type |
Secondary
|
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End point timeframe |
From Week 16, Up to Week 32
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| Notes [65] - ADHD + Dyslexia, ADHD Alone: n = 5 [66] - ADHD + Dyslexia: n = 6 ADHD Alone: n = 5 |
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| No statistical analyses for this end point | |||||||||||||||||||
|
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End point title |
Change from Baseline to Endpoint in ADHDRS-IV Total Score in Participants with Dyslexia Alone | ||||||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
||||||||||||
|
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| No statistical analyses for this end point | |||||||||||||
|
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End point title |
Change from Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants with ADHD or ADHD + Dyslexia | ||||||||||||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. APD: All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
From Week 16, Up to Week 32
|
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|
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| Notes [67] - ADHD + Dyslexia, ADHD alone: n = 5 [68] - ADHD + Dyslexia: n = 19 ADHD alone: n = 13 |
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| No statistical analyses for this end point | |||||||||||||||||||
|
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End point title |
The Number of Participants with Treatment Emergent Adverse Events (TEAE) in Participants with Dyslexia [69] | |||||||||
End point description |
The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. APD: All randomized participants who received at least one dose of study drug.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
16 Weeks
|
|||||||||
| Notes [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||||||||
End point title |
The Number of Participants with TEAE in Participants with ADHD or ADHD+Dyslexia. [70] | |||||||||||||||
End point description |
The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. APD: All randomized participants who received at least one dose of study drug.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
16 Weeks
|
|||||||||||||||
| Notes [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
||||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
|||||||||||||
End point title |
The Number of Participants with TEAE in Participants with Dyslexia | ||||||||||||
End point description |
The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. APD: All randomized participants who received at least one dose of study drug.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From 16 Weeks Up to Week 32
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||
End point title |
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. | ||||||||||||||||||||
End point description |
The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. APD: All randomized participants who received at least one dose of study drug.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Week 16 Up to Week 32
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Number of Participants with Adverse Events [71] | ||||||||||||||||||
End point description |
Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. APD: All randomized participants who received at least one dose of study drug.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
32 Weeks
|
||||||||||||||||||
| Notes [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants [72] | ||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. APD: All healthy participants who had evaluable baseline and post baseline WJ III measurements.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||||||||||||||||
| Notes [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||
End point title |
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants [73] | ||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. APD: All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||||
| Notes [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Healthy Participants [74] | ||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. APD: All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 16 weeks
|
||||||||||||||||||
| Notes [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||
End point title |
Change from Baseline to Endpoint TOWRE Total Score in Healthy Participants [75] | ||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction. APD: All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||
| Notes [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in WMTB-C in Healthy Participants [76] | ||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). APD: All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||||||||||||||||||||
| Notes [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||
End point title |
Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants [77] | ||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction. APD: All participants who had evaluable baseline and post baseline BADD-A measurements.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||
| Notes [77] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change from Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants [78] | ||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. APD: All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 16 Weeks
|
||||||||
| Notes [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||
End point title |
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants [79] | ||||||||||||||||||||||||||
End point description |
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. APD: All healthy participants who had baseline and post-baseline WJ III measurements.
|
||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||||||||||
| Notes [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||
|
|||||||||||||||
End point title |
Change from Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants [80] | ||||||||||||||
End point description |
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. APD: All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Baseline, 32 weeks
|
||||||||||||||
| Notes [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The endpoint is planned only for these reporting arms in the baseline period. |
|||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||
End point title |
Change from Baseline to Endpoint in GORT-4 in Healthy Participants | ||||||||||||||||||
End point description |
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. APD: All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||
End point title |
Change from Baseline to Endpoint in TOWRE Total Score in Healthy Participants | ||||||||
End point description |
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. APD: All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, 32 Weeks
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||
End point title |
Change from Baseline to Endpoint in WMTB-C in Healthy Participants | ||||||||||||||||||||||||||
End point description |
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). APD: All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
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End point type |
Secondary
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End point timeframe |
Baseline, 32 Weeks
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End point title |
Change from Baseline to Endpoint in BADD-A Total Score in Healthy Participants | ||||||||
End point description |
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. APD: All healthy participants who had evaluable baseline and post baseline BADD-A measurements.
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End point type |
Secondary
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End point timeframe |
Baseline, 32 Weeks
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End point title |
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants | ||||||||
End point description |
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. APD: All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
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End point type |
Secondary
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End point timeframe |
Baseline, 32 Weeks
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Adverse events information
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Timeframe for reporting adverse events |
Baseline Up To 34 Weeks
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Adverse event reporting additional description |
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Atomoxetine - Acute Phase (SPII)
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Reporting group description |
Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo - Acute Phase (SPII)
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Reporting group description |
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo/Atomoxetine - Rerandomization Phase (SPIII)
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Reporting group description |
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Atomoxetine/Placebo - Rerandomization Phase (SPIII)
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Reporting group description |
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Atomoxetine/Atomoxetine - Rerandomization Phase (SPIII)
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Reporting group description |
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Oct 2012 |
- Addition of Synopsis
- Update of safety reporting
- Objectives were updated to organize all objectives based on patient diagnostic criteria
- Exclusion Criteria was updated to exclude subjects weighing 25 kg or less
- Treatments Administered required a change as a result of the unavailability of the 2.5 mg and 5 mg capsules and a 10 mg clinical trial package which are needed for the 18 to 25 kg weight range. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
