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    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
    EudraCT number
    		 2012-001568-31
    Trial protocol
    		 GB   HU   BE   ES   NL   EE   FR   IT   IS  
    Global end of trial date
    11 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEM-MD-68
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01592747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Forest Laboratories LLC, a subsidiary of Allergan, plc
    Sponsor organisation address
    1 Grand Canal Square, Docklands, Ireland, Dublin 2
    Public contact
    Clinical Trial Information Desk, Forest Laboratories LLC, a subsidiary of Allergan, plc, 001 866-369-5227,
    Scientific contact
    Joel Trugman, Forest Laboratories LLC, a subsidiary of Allergan, plc, 001 201-427-8681, Joel.Trugman@actavis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    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).
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 Not Applicable
    Actual start date of recruitment
    10 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Colombia: 5
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Iceland: 3
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Ukraine: 6
    Country: Number of subjects enrolled
    United States: 386
    Worldwide total number of subjects
    479
    EEA total number of subjects
    51
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    418
    Adolescents (12-17 years)
    61
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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
    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
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Dose-matched placebo, oral administration, once per day.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose-matched placebo, oral administration, once per day.

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Ebixa, Namenda, Axura, Akatinol, Abixa, Memox
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    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.

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Ebixa, Namenda, Axura, Akatinol, Abixa, Memox
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.

    Number of subjects in period 1
    		Placebo Memantine Reduced Dose Memantine Full-Dose
    Started
    160
    161
    158
    Completed
    44
    50
    50
    Not completed
    116
    111
    108
         Consent withdrawn by subject
    2
    -
    2
         Loss of Therapeutic Response
    107
    108
    100
         Adverse event, non-fatal
    1
    -
    -
         Other Reasons
    1
    1
    -
         Lost to follow-up
    1
    -
    1
         Did meet Includsion/Exclusion criteria
    -
    1
    1
         Protocol deviation
    4
    -
    4
         Lack of efficacy
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Dose-matched placebo, oral administration, once per day.

    Reporting group title
    Memantine Reduced Dose
    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
    Reporting group description
    		 Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.

    Reporting group values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose Total
    Number of subjects
    		 160 161 158 479
    Age categorical
    Units: Subjects
        Children (6-12 years)
    		 160 161 158 479
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.9 ( 2 ) 9.2 ( 1.9 ) 9.2 ( 1.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 28 26 72
        Male
    		 142 133 132 407

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Dose-matched placebo, oral administration, once per day.

    Reporting group title
    Memantine Reduced Dose
    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
    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
    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.)

    Subject analysis set title
    Memantine Reduced Dose
    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.)

    Subject analysis set title
    Memantine Full Dose
    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.)

    Primary: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study

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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.
    End point type
    Primary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full Dose
    Number of subjects analysed
    158
    160
    153
    Units: Percentage of patients with LTR
        number (not applicable)
    69
    67.5
    66.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Memantine Full Dose v Placebo
    Number of subjects included in analysis
    311
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.659 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.8
    Notes
    [1] - Cochran-Mantel-Haensze test controlling for Autistic Spectrum Disorder subtype.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Memantine Reduced Dose
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7839 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.7
    Notes
    [2] - Cochran-Mantel-Haenszel test controlling for Autistic Spectrum Disorder subtype.

    Secondary: Time to First Loss of Therapeutic (LTR) Response

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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.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full Dose
    Number of subjects analysed
    158
    160
    153
    Units: Days
        median (confidence interval 95%)
    29 (28 to 42)
    33 (28 to 56)
    30 (28 to 44)
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    153
    160
    158
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.2 ( 2.7 )
    0.2 ( 2.7 )
    0.3 ( 2.6 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Syntax Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.1 ( 2.9 )
    0.6 ( 2.9 )
    0.4 ( 2.7 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Semantics Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.5 ( 2.6 )
    1 ( 2.9 )
    0.7 ( 2.6 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Coherence Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard error)
    0.8 ( 3.4 )
    1.2 ( 3.8 )
    1.2 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Initiation Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard error)
    1.3 ( 3.1 )
    1.5 ( 3.7 )
    1.1 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Scripted Language Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard error)
    0.8 ( 2.9 )
    1.2 ( 3.2 )
    1 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Context Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.9 ( 3 )
    0.9 ( 3.8 )
    0.9 ( 3.2 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    1.3 ( 3.2 )
    1.6 ( 3.8 )
    1.7 ( 3.5 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Social Relations Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    153
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    1.6 ( 2.9 )
    1.9 ( 3.7 )
    1.7 ( 3.7 )
    No statistical analyses for this end point

    Secondary: Change in Children’s Communication Checklist-2 (CCC-2) - Interests Subscale

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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).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) to week 12
    End point values
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Number of subjects analysed
    158
    160
    158
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.8 ( 3.3 )
    1.3 ( 3.7 )
    1.2 ( 3.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Dose-matched placebo, oral administration, once per day.

    Reporting group title
    Memantine Reduced Dose
    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
    Reporting group description
    		 Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.

    Serious adverse events
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 160 (0.63%)
    0 / 157 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Furuncle
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 160 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Memantine Reduced Dose Memantine Full-Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 160 (5.00%)
    5 / 160 (3.13%)
    4 / 157 (2.55%)
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    8 / 160 (5.00%)
    5 / 160 (3.13%)
    4 / 157 (2.55%)
         occurrences all number
    8
    5
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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