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Trial record 34 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00872898
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Memantine - Extended Release (ER)
Drug: Placebo
Enrollment 124
Recruitment Details Patients for Part One of the study were recruited during a 15 month period from April of 2009, to June of 2010. Patients for Part Two of the study were recruited for a 37 month period from April of 2009 to April of 2012. All study sites were located in the United States.
Pre-assignment Details Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description Once daily, oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Period Title: Part One - Open Label, Pharmacokinetics
Started 0 4
Completed 0 4
Not Completed 0 0
Period Title: Part Two - Double Blind
Started 61 60
Completed 50 54
Not Completed 11 6
Reason Not Completed
Adverse Event             4             3
Lack of Efficacy             1             0
Protocol Violation             1             0
Withdrawal by Subject             3             1
Lost to Follow-up             0             2
Other reasons             2             0
Arm/Group Title Part One - Memantine Part Two - Placebo Part Two - Memantine Total
Hide Arm/Group Description Patients received a single dose of 3-mg memantine extended release capsule, oral administration. Once daily oral administration of placebo for 12 weeks. Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups. Total of all reporting groups
Overall Number of Baseline Participants 3 61 60 124
Hide Baseline Analysis Population Description
Part One of the study enrolled 4 patients to determine a safe dosing regimen for Part Two along with data collected for 14 patients enrolled in study MEM-PK-21. One patient from Part One of the study also enrolled in Part Two. The 121 patients enrolled in Part Two were randomized after two weeks of single-blind placebo treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
6 years to 18 years Number Analyzed 3 participants 61 participants 60 participants 124 participants
9.0  (2.6) 8.9  (2.2) 9.0  (2.2) 9.0  (0.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 61 participants 60 participants 124 participants
6 years to 12 years 3 60 59 122
13 years to 18 years 0 1 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 61 participants 60 participants 124 participants
Female
2
  66.7%
12
  19.7%
8
  13.3%
22
  17.7%
Male
1
  33.3%
49
  80.3%
52
  86.7%
102
  82.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 61 participants 60 participants 124 participants
3 61 60 124
1.Primary Outcome
Title Extent of Absorption of Memantine (Part One)
Hide Description Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.
Time Frame Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)
Arm/Group Title Memantine
Hide Arm/Group Description:
Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
682.53  (217.77)
2.Primary Outcome
Title Change in Total Raw Score of Social Responsiveness Scale
Hide Description

The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, 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.

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.5  (2.6) -9.6  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9781
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-7.2 to 7.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Core Autism Treatment Scale-Improvement: Total Score
Hide Description

The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).

The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).

Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
50.4  (1.0) 48.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1197
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-4.9 to 0.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Core Autism Treatment Scale-Improvement: Social Interaction
Hide Description

The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).

The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).

Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily, oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
32.4  (0.7) 31.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1459
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.2 to 0.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Core Autism Treatment Scale-Improvement: Communication
Hide Description

The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).

The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).

Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily, oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
18.0  (0.4) 17.2  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1344
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.9 to 0.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.4  (0.5) -0.7  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7000
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.5 to 1.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.1  (0.4) -1.2  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9069
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.3 to 1.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.2  (0.3) -0.5  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4679
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.2 to 0.6
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.2  (0.5) -1.2  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9598
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-1.3 to 1.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.8  (0.5) -0.9  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9898
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-1.3 to 1.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.4) -0.5  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4228
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.7 to 1.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.5  (0.4) -0.2  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.2 to 2.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.7  (0.4) -0.9  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6889
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.3 to 0.9
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale
Hide 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).

Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
Hide Arm/Group Description:
Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.0  (0.4) -0.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7481
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.9 to 1.2
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale
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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).

Time Frame From Baseline to Week 12
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Hide Analysis Population Description
All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.
Arm/Group Title Placebo Memantine
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Once daily oral administration of placebo for 12 weeks.

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.

Overall Number of Participants Analyzed 53 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.5  (0.4) -0.5  (0.4)
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Statistical Analysis Overview Comparison Group Selection Placebo, Memantine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9500
Comments [Not Specified]
Method mixed-model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-1.2 to 1.1
Estimation Comments [Not Specified]
Time Frame Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Part Two, Double-Blind Treatment Memantine - Part Two, Double-Blind Treatment Memantine - Part One, Open Label Treatment
Hide Arm/Group Description Once daily oral administration of placebo for 12 weeks

Once daily oral administration of memantine extended release for 12 weeks.

Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.

Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
All-Cause Mortality
Placebo - Part Two, Double-Blind Treatment Memantine - Part Two, Double-Blind Treatment Memantine - Part One, Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
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Placebo - Part Two, Double-Blind Treatment Memantine - Part Two, Double-Blind Treatment Memantine - Part One, Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   1/60 (1.67%)   0/4 (0.00%) 
Psychiatric disorders       
Affective Disorder  1  0/61 (0.00%)  1/60 (1.67%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Part Two, Double-Blind Treatment Memantine - Part Two, Double-Blind Treatment Memantine - Part One, Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/61 (50.82%)   37/60 (61.67%)   1/4 (25.00%) 
Gastrointestinal disorders       
Vomiting  1  6/61 (9.84%)  4/60 (6.67%)  0/4 (0.00%) 
General disorders       
Irritability  1  3/61 (4.92%)  5/60 (8.33%)  0/4 (0.00%) 
Pyrexia  1  4/61 (6.56%)  2/60 (3.33%)  0/4 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  1  7/61 (11.48%)  6/60 (10.00%)  0/4 (0.00%) 
Influenza  1  2/61 (3.28%)  4/60 (6.67%)  0/4 (0.00%) 
Nasopharyngitis  1  6/61 (9.84%)  2/60 (3.33%)  0/4 (0.00%) 
Nervous system disorders       
Headache  1  3/61 (4.92%)  3/60 (5.00%)  1/4 (25.00%) 
Psychomotor hyperactivity  1  4/61 (6.56%)  1/60 (1.67%)  0/4 (0.00%) 
Anxiety  1  4/61 (6.56%)  0/60 (0.00%)  0/4 (0.00%) 
Psychiatric disorders       
Aggression  1  3/61 (4.92%)  5/60 (8.33%)  0/4 (0.00%) 
Agitation  1  1/61 (1.64%)  4/60 (6.67%)  0/4 (0.00%) 
Insomnia  1  3/61 (4.92%)  4/60 (6.67%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/61 (4.92%)  6/60 (10.00%)  0/4 (0.00%) 
Rhinorrhoea  1  0/61 (0.00%)  3/60 (5.00%)  0/4 (0.00%) 
Nasal congestion  1  5/61 (8.20%)  1/60 (1.67%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

All data generated in this study are the property of Forest Research Institute. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute.

Results Point of Contact
Name/Title: Ephraim Katz, PhD / Associate Director
Organization: Forest Research Institute
Phone: 201-427-8000 ext 8169
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00872898     History of Changes
Other Study ID Numbers: MEM-MD-57A
First Submitted: March 30, 2009
First Posted: March 31, 2009
Results First Submitted: August 1, 2013
Results First Posted: January 14, 2014
Last Update Posted: January 14, 2014