Trial Outcomes & Findings for Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine (NCT NCT01592747)
NCT ID: NCT01592747
Last Updated: 2019-04-24
Results Overview
Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score 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.
COMPLETED
PHASE2
479 participants
Baseline (Visit 1) to week 12
2019-04-24
Participant Flow
Patient recruitment occurred over a ten month period, from September of 2012 to June of 2013, at 92 study sites, located in the Untied States and 14 other countries.
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 MEM-MD-91 were eligible to enroll into this study.
Participant milestones
| Measure |
Placebo
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
|
Memantine Full-Dose
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg, depending on weight group and tolerability. Oral administration, once per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
160
|
161
|
158
|
|
Overall Study
COMPLETED
|
44
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
116
|
111
|
108
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
|
Memantine Full-Dose
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg, depending on weight group and tolerability. Oral administration, once per day.
|
|---|---|---|---|
|
Overall Study
Loss of Therapeutic Response
|
107
|
108
|
100
|
|
Overall Study
Inclusion/Exclusion criteria not met
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
4
|
0
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Other Reasons
|
1
|
1
|
0
|
Baseline Characteristics
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Baseline characteristics by cohort
| Measure |
Placebo
n=160 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=160 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration once per day.
|
Memantine Full-Dose
n=157 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg depending on weight group and tolerability. Oral administration, once per day.
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
138 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
419 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
406 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
134 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Iceland
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Autism Spectrum Disorder Subtype
Autism
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Autism Spectrum Disorder Subtype
Asperger's Disorder
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Autism Spectrum Disorder Subtype
PDD-NOS
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: 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.)
Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score 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.
Outcome measures
| Measure |
Placebo
n=158 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=160 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases)
|
69.0 Percentage of patients with LTR
|
67.5 Percentage of patients with LTR
|
66.7 Percentage of patients with LTR
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: 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.)
Time to the first visit when a patient shows LTR following randomization to memantine or placebo.
Outcome measures
| Measure |
Placebo
n=158 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=160 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Time to First Loss of Therapeutic (LTR) Response
|
29 Days
Interval 28.0 to 42.0
|
33 Days
Interval 28.0 to 56.0
|
30 Days
Interval 28.0 to 44.0
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12
|
0.1 units on a scale
Standard Error 0.2
|
0.1 units on a scale
Standard Error 0.2
|
0.2 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12
|
0.0 units on a scale
Standard Error 0.2
|
0.3 units on a scale
Standard Error 0.2
|
0.1 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12
|
0.3 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
0.3 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12
|
0.7 units on a scale
Standard Error 0.3
|
1.0 units on a scale
Standard Error 0.3
|
1.0 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12
|
1.4 units on a scale
Standard Error 0.3
|
1.6 units on a scale
Standard Error 0.3
|
1.2 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12
|
0.8 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12
|
0.9 units on a scale
Standard Error 0.3
|
0.8 units on a scale
Standard Error 0.3
|
0.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12
|
1.2 units on a scale
Standard Error 0.3
|
1.5 units on a scale
Standard Error 0.3
|
1.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale at Week 12
|
1.5 units on a scale
Standard Error 0.3
|
1.8 units on a scale
Standard Error 0.3
|
1.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to week 12Population: Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. 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).
Outcome measures
| Measure |
Placebo
n=154 Participants
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=159 Participants
Memantine, 3mg every other day, 3mg per day, or 6mg per day depending on weight group and tolerability. Oral administration, once per day.
|
Memantine Full-Dose
n=153 Participants
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Interests Subscale at Week 12
|
0.9 units on a scale
Standard Error 0.3
|
1.3 units on a scale
Standard Error 0.3
|
1.2 units on a scale
Standard Error 0.3
|
Adverse Events
Placebo
Memantine Reduced Dose
Memantine Full-Dose
Serious adverse events
| Measure |
Placebo
n=160 participants at risk
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=160 participants at risk
Memantine, 3mg every other day, 3mg per day, or 6mg per day. Oral administration.
|
Memantine Full-Dose
n=157 participants at risk
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
Infections and infestations
Furuncle
|
0.00%
0/160 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
0.62%
1/160 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
0.00%
0/157 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
Other adverse events
| Measure |
Placebo
n=160 participants at risk
Dose-matched placebo, oral administration, once per day.
|
Memantine Reduced Dose
n=160 participants at risk
Memantine, 3mg every other day, 3mg per day, or 6mg per day. Oral administration.
|
Memantine Full-Dose
n=157 participants at risk
Memantine, 3mg, 6mg, 9mg, 12mg or 15mg; oral administration. Once per day.
|
|---|---|---|---|
|
General disorders
Irritability
|
5.0%
8/160 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
3.1%
5/160 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
2.5%
4/157 • Adverse events were collected for a 14 month period from September of 2012 to October of 2013 at 92 study centers in the United States and 14 other countries.
Safety results are based on Safety Population (ie, all randomized patients who took at least 1 dose of double-blind study drug).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study are the property of Forest Research Institute, Inc. 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, Inc.
- Publication restrictions are in place
Restriction type: OTHER