Trial · NCT01592786
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
NCT01592786, Phase 2, Completed, Forest Laboratories; results first posted 2014-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). Trials, record NCT01592786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592786
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- NCT number
- NCT01592786
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 906 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- Interventions
- Memantine Hydrochloride (HCl)
- First posted
- 2012-05-07
- Last updated
- 2014-08-07
- Results first posted
- 2014-08-07
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Confirmed Social Responsiveness Scale (SRS) Responders | Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) | A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks. The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Confirmed Social Responsiveness Scale (SRS) Responders | Visit 1 (Baseline) to Visit 8 (week 48/Final Visit) | Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post-Visit 1 assessment of the SRS total raw score. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Confirmed Social Responsiveness Scale (SRS) Responders | Memantine Hydrochloride (HCl) | Responders | 517 | participants | |
| Number of Confirmed Social Responsiveness Scale (SRS) Responders | Memantine Hydrochloride (HCl) | Non responders | 351 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Memantine Hydrochloride (HCl) | 903 | |
| Overall Study | COMPLETED | Memantine Hydrochloride (HCl) | 765 | |
| Overall Study | NOT COMPLETED | Memantine Hydrochloride (HCl) | 138 |
Source ClinicalTrials.gov
Adverse events9
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 | Pyrexia | General disorders | Memantine Hydrochloride (HCl) | 52 | 903 | |
| other | Irritability | General disorders | Memantine Hydrochloride (HCl) | 49 | 903 | |
| other | Nasopharyngitis | Infections and infestations | Memantine Hydrochloride (HCl) | 57 | 903 | |
| other | Headache | Nervous system disorders | Memantine Hydrochloride (HCl) | 72 | 903 | |
| serious | Abnormal behaviour | Psychiatric disorders | Memantine Hydrochloride (HCl) | 2 | 903 | |
| serious | Accidental exposure | Injury, poisoning and procedural complications | Memantine Hydrochloride (HCl) | 1 | 903 | |
| serious | Constipation | Gastrointestinal disorders | Memantine Hydrochloride (HCl) | 1 | 903 | |
| serious | Disinhibition | Psychiatric disorders | Memantine Hydrochloride (HCl) | 1 | 903 | |
| serious | Gastroenteritis | Gastrointestinal disorders | Memantine Hydrochloride (HCl) | 1 | 903 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Memantine Hydrochloride (HCl) | ||
| Total, other adverse events | Memantine Hydrochloride (HCl) | 196 | 903 |
| Total, serious adverse events | Memantine Hydrochloride (HCl) | 6 | 903 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01592786
GET https://conductscience.org/api/trials/v1/NCT01592786/registered