Clinical Trial Results:
Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)
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Summary
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EudraCT number |
2009-011426-33 |
Trial protocol |
ES NL SE |
Global end of trial date |
03 May 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jun 2018
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First version publication date |
10 Jun 2018
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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-EW-LYEN
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01127646 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Trial Number: 13070 | ||
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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 |
03 May 2011
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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 |
03 May 2011
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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 |
The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.
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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 |
22 Jun 2010
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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 |
Netherlands: 1
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Country: Number of subjects enrolled |
Spain: 20
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Country: Number of subjects enrolled |
Sweden: 2
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Worldwide total number of subjects |
23
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EEA total number of subjects |
23
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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) |
14
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Adolescents (12-17 years) |
9
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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 |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Not Applicable | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer | ||||||||||||||||||
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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 |
Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Atomoxetine
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Investigational medicinal product code |
LY139603
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Other name |
Strattera
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
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Arm title
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Osmotic-Release Oral System (OROS) Methylphenidate | ||||||||||||||||||
Arm description |
Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Osmotic-Release Oral System (OROS) Methylphenidate
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Investigational medicinal product code |
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Other name |
Concerta
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
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Baseline characteristics reporting groups
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Reporting group title |
Atomoxetine
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Reporting group description |
Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Osmotic-Release Oral System (OROS) Methylphenidate
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Reporting group description |
Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atomoxetine
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Reporting group description |
Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||
Reporting group title |
Osmotic-Release Oral System (OROS) Methylphenidate
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Reporting group description |
Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. | ||
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End point title |
Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days versus Off-Days) During the 4-Week Treatment Period [1] | |||||||||
End point description |
Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Primary
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End point timeframe |
Baseline through 4 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: Zero participants were analyzed due to trial termination. Therefore, no inferential statistics were planned or conducted for this endpoint. |
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| Notes [2] - Zero participants were analyzed due to trial termination. [3] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period | |||||||||
End point description |
Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.
Analysis Population Description: No data displayed because Outcome Measure has zero total participants analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [4] - Zero participants were analyzed due to trial termination. [5] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period | |||||||||
End point description |
The teacher version of Conners’ Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner’s Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [6] - Zero participants were analyzed due to trial termination. [7] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items during the 4-Week Treatment Period | |||||||||
End point description |
Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [8] - Zero participants were analyzed due to trial termination. [9] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4 | |||||||||
End point description |
Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 3, and 4
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| Notes [10] - Zero participants were analyzed due to trial termination. [11] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4 | |||||||||
End point description |
This instrument is a single-item expert rating of the severity of the participant’s attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor’s total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.
Analysis Population Description: No data displayed because Outcome Measure has zero total participants analyzed.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 3, and 4
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| Notes [12] - Zero participants were analyzed due to trial termination. [13] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5 | |||||||||
End point description |
29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1="not at all true" to 5="very much true"). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Up to Week 5
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| Notes [14] - Zero participants were analyzed due to trial termination. [15] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period | |||||||||
End point description |
Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [16] - Zero participants were analyzed due to trial termination. [17] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period | |||||||||
End point description |
6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 ("I totally agree") to 5 ("I totally disagree"). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [18] - Zero participants were analyzed due to trial termination. [19] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period | |||||||||
End point description |
Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [20] - Zero participants were analyzed due to trial termination. [21] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period | |||||||||
End point description |
The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners’ Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Baseline through 4 weeks
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| Notes [22] - Zero participants were analyzed due to trial termination. [23] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4 | |||||||||
End point description |
Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.
Analysis Population Description: No participants had data analyzed due to the termination of the trial and the insufficient sample size.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 3, and 4
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| Notes [24] - Zero participants were analyzed due to trial termination. [25] - Zero participants were analyzed due to trial termination. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change from Baseline in Heart Rate up to 5 Weeks | ||||||||||||
End point description |
Analysis Population Description: Safety population: all participants who entered the study and took at least 1 dose of study medication.
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End point type |
Other pre-specified
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End point timeframe |
Baseline, up to 5 weeks
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks | ||||||||||||||||||
End point description |
Analysis Population Description: Safety population: all participants who entered the study and took at least 1 dose of study medication.
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End point type |
Other pre-specified
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End point timeframe |
Baseline, up to 5 weeks
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected for the entire study period, which included the following: 3-14 day screening period, a run-in period of up to 7 days, a 4-week on/off period, and a 1-5 day run-out period for a maximum of 54 days.
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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 |
14.0
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Reporting groups
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Reporting group title |
Osmotic-Release Oral System (OROS) Methylphenidate
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Reporting group description |
Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Atomoxetine
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Reporting group description |
Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| This study (Study LYEN) was terminated after enrolling 23 participants due to lack of availability of study participants to accommodate the study design. | |||
