Trial · NCT01592747
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
NCT01592747, Phase 2, Completed, Forest Laboratories; results first posted 2019-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine. Trials, record NCT01592747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
- NCT number
- NCT01592747
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 479 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome, Autism Spectrum Disorders, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
- Interventions
- Memantine Hydrochloride (HCl), Memantine Hydrochloride (HCl), Placebo capsules
- First posted
- 2012-05-07
- Last updated
- 2019-04-24
- Results first posted
- 2019-04-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) | Baseline (Visit 1) to week 12 | 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. |
| Secondary | Time to First Loss of Therapeutic (LTR) Response | Baseline to week 12 | Time to the first visit when a patient shows LTR following randomization to memantine or placebo. |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
| Secondary | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) | Baseline (Visit 1) to week 12 | 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.) | Percentage of patients with LTR | NUMBER |
| SECONDARY | Time to First Loss of Therapeutic (LTR) Response | Baseline to week 12 | 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.) | Days | MEDIAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12 | Baseline (Visit 1) to week 12 | 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). | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) | Placebo | 69.0 | Percentage of patients with LTR | ||
| Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) | Memantine Reduced Dose | 67.5 | Percentage of patients with LTR | ||
| Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) | Memantine Full-Dose | 66.7 | Percentage of patients with LTR | ||
| Time to First Loss of Therapeutic (LTR) Response | Placebo | 29 | 95% Confidence Interval 28 to 42 | Days | |
| Time to First Loss of Therapeutic (LTR) Response | Memantine Reduced Dose | 33 | 95% Confidence Interval 28 to 56 | Days | |
| Time to First Loss of Therapeutic (LTR) Response | Memantine Full-Dose | 30 | 95% Confidence Interval 28 to 44 | Days | |
| Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12 | Placebo | 0.1 | Standard Error 0.2 | units on a scale | |
| Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12 | Memantine Reduced Dose | 0.1 | Standard Error 0.2 | units on a scale | |
| Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12 | Memantine Full-Dose | 0.2 | Standard Error 0.2 | units on a scale | |
| Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12 | Placebo | 0.0 | Standard Error 0.2 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 160 | |
| Overall Study | STARTED | Memantine Reduced Dose | 161 | |
| Overall Study | STARTED | Memantine Full-Dose | 158 | |
| Overall Study | COMPLETED | Placebo | 44 | |
| Overall Study | COMPLETED | Memantine Reduced Dose | 50 | |
| Overall Study | COMPLETED | Memantine Full-Dose | 50 | |
| Overall Study | NOT COMPLETED | Placebo | 116 | |
| Overall Study | NOT COMPLETED | Memantine Reduced Dose | 111 | |
| Overall Study | NOT COMPLETED | Memantine Full-Dose | 108 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Irritability | General disorders | Placebo | 8 | 160 | |
| other | Irritability | General disorders | Memantine Reduced Dose | 5 | 160 | |
| other | Irritability | General disorders | Memantine Full-Dose | 4 | 157 | |
| serious | Furuncle | Infections and infestations | Placebo | 0 | 160 | |
| serious | Furuncle | Infections and infestations | Memantine Reduced Dose | 1 | 160 | |
| serious | Furuncle | Infections and infestations | Memantine Full-Dose | 0 | 157 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Memantine Reduced Dose | ||
| Total, all-cause mortality | Memantine Full-Dose | ||
| Total, other adverse events | Placebo | 8 | 160 |
| Total, other adverse events | Memantine Reduced Dose | 5 | 160 |
| Total, other adverse events | Memantine Full-Dose | 4 | 157 |
| Total, serious adverse events | Placebo | 0 | 160 |
| Total, serious adverse events | Memantine Reduced Dose | 1 | 160 |
| Total, serious adverse events | Memantine Full-Dose | 0 | 157 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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