Clinical Trial Results:
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
Summary
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EudraCT number |
2012-001568-31 |
Trial protocol |
GB HU BE ES NL EE FR IT IS |
Global end of trial date |
11 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Aug 2018
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First version publication date |
09 Aug 2018
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Other versions |
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 |
MEM-MD-68
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01592747 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Forest Laboratories LLC, a subsidiary of Allergan, plc
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Sponsor organisation address |
1 Grand Canal Square, Docklands, Ireland, Dublin 2
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Public contact |
Clinical Trial Information Desk, Forest Laboratories LLC, a subsidiary of Allergan, plc, 001 866-369-5227,
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Scientific contact |
Joel Trugman, Forest Laboratories LLC, a subsidiary of Allergan, plc, 001 201-427-8681, Joel.Trugman@actavis.com
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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 |
07 Oct 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Sep 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Sep 2013
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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 |
To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.
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Protection of trial subjects |
At each study center, the Investigator was responsible for ensuring that the investigation
was conducted according to the signed Investigator agreement, the protocol, good clinical
practice guidelines, and applicable regulations; for protecting the rights, safety, and
welfare of patients under the Investigator’s care; and for the control of investigational
products under investigation. The Investigator at each study center was responsible for
the management of the study, which consisted of maintaining the study file and patient
records, corresponding with the IRB/IEC, and completing the electronic case report
forms (eCRFs).
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Background therapy |
Not Applicable | ||
Evidence for comparator |
Not Applicable | ||
Actual start date of recruitment |
10 Sep 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Belgium: 4
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Country: Number of subjects enrolled |
Colombia: 5
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Country: Number of subjects enrolled |
Estonia: 2
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Country: Number of subjects enrolled |
France: 7
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Country: Number of subjects enrolled |
Hungary: 8
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Country: Number of subjects enrolled |
Iceland: 3
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Country: Number of subjects enrolled |
Italy: 4
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Country: Number of subjects enrolled |
Korea, Republic of: 14
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Country: Number of subjects enrolled |
New Zealand: 2
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Country: Number of subjects enrolled |
Poland: 21
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Country: Number of subjects enrolled |
Serbia: 14
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Country: Number of subjects enrolled |
South Africa: 1
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
Ukraine: 6
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Country: Number of subjects enrolled |
United States: 386
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Worldwide total number of subjects |
479
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EEA total number of subjects |
51
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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) |
418
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Adolescents (12-17 years) |
61
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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 |
Patient recruitment occurred over an ten month period, from September of 2012 to June of 2013, at 92 study sites, located in 15 countries. Belgium Colombia Estonia France Hungary Iceland Italy Korea, Republic of New Zealand Poland Serbia South Africa Spain Ukraine United States | ||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Patients who completed at least 12 weeks of exposure to open-label memantine and met the responder criterion at 2 consecutive visits separated by at least 2 weeks during lead-in study 2012-001568-31 (MEM-MD-91) were eligible to be randomized into this study. | ||||||||||||||||||||||||||||||||||||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Monitor, Subject, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Dose-matched placebo, oral administration, once per 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 |
Dose-matched placebo, oral administration, once per day.
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Arm title
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Memantine Reduced Dose | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day. | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Memantine
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Investigational medicinal product code |
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Other name |
Ebixa, Namenda, Axura, Akatinol, Abixa, Memox
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
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Arm title
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Memantine Full-Dose | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day. | ||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Memantine
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Investigational medicinal product code |
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Other name |
Ebixa, Namenda, Axura, Akatinol, Abixa, Memox
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration,
once per day.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Dose-matched placebo, oral administration, once per day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Memantine Reduced Dose
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Reporting group description |
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Memantine Full-Dose
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Reporting group description |
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Dose-matched placebo, oral administration, once per day. | ||
Reporting group title |
Memantine Reduced Dose
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Reporting group description |
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day. | ||
Reporting group title |
Memantine Full-Dose
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Reporting group description |
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day. | ||
Subject analysis set title |
Placebo
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All efficacy analyses were based on the Intent-to-treat (ITT) Population. Of the 479 randomized patients, 471 patients were in the ITT Population (ie, had at least 1 dose of double-blind investigational product and at least 1 assessment of the Social Responsiveness Scale (SRS) total raw score during the double-blind treatment period.)
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Subject analysis set title |
Memantine Reduced Dose
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All efficacy analyses were based on the Intent-to-treat (ITT) Population. Of the 479 randomized patients, 471 patients were in the ITT Population (ie, had at least 1 dose of double-blind investigational product and at least 1 assessment of the Social Responsiveness Scale (SRS) total raw score during the double-blind treatment period.)
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Subject analysis set title |
Memantine Full Dose
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All efficacy analyses were based on the Intent-to-treat (ITT) Population. Of the 479 randomized patients, 471 patients were in the ITT Population (ie, had at least 1 dose of double-blind investigational product and at least 1 assessment of the Social Responsiveness Scale (SRS) total raw score during the double-blind treatment period.)
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End point title |
Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study | ||||||||||||||||
End point description |
Loss of Therapeutic response is defined as an increase of at least 10 points (worsening) in Social Responsiveness Scale (SRS) total raw score at any double-blind visit (Visits 2, 3, 4, 5, 6, or 7) relative to the Visit 1 (randomization) score.
The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment with total raw score, ranging from 0 (no impairment) to 195 (severe social impairment).
Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.
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End point type |
Primary
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End point timeframe |
Baseline (Visit 1) to week 12
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||
Comparison groups |
Memantine Full Dose v Placebo
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Number of subjects included in analysis |
311
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.659 [1] | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||
Point estimate |
1.1
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.7 | ||||||||||||||||
upper limit |
1.8 | ||||||||||||||||
Notes [1] - Cochran-Mantel-Haensze test controlling for Autistic Spectrum Disorder subtype. |
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Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||
Comparison groups |
Placebo v Memantine Reduced Dose
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Number of subjects included in analysis |
318
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.7839 [2] | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||
Point estimate |
1.1
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
0.7 | ||||||||||||||||
upper limit |
1.7 | ||||||||||||||||
Notes [2] - Cochran-Mantel-Haenszel test controlling for Autistic Spectrum Disorder subtype. |
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End point title |
Time to First Loss of Therapeutic (LTR) Response | ||||||||||||||||
End point description |
Time to the first visit when a patient shows LTR following randomization to memantine or placebo.
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End point type |
Secondary
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End point timeframe |
Baseline to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Syntax Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Semantics Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Coherence Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Initiation Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Scripted Language Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Scripted language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Context Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Nonverbal communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Social Relations Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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No statistical analyses for this end point |
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End point title |
Change in Children’s Communication Checklist-2 (CCC-2) - Interests Subscale | ||||||||||||||||
End point description |
The Children's Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 1) to week 12
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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 events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in 15 countries.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Dose-matched placebo, oral administration, once per day. | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Memantine Reduced Dose
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Reporting group description |
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day. | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Memantine Full-Dose
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Reporting group description |
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day. | ||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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22 Mar 2013 |
The following changes have been made globally to the protocol:
All references to the Social Responsiveness Scale (SRS) Parent Autoscore version
have been revised because the SRS Parent Autoscore version has not been provided
to the sites. The SRS total raw score should be calculated before the caregiver leaves
the site. The global change is as follows, “If for any reason the data cannot be entered
in EDC, Forest must be contacted immediately before the patient/caregiver leave the site. |
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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 |