Trial · NCT01592773
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
NCT01592773, Phase 2, Terminated, Forest Laboratories; results first posted 2015-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). Trials, record NCT01592773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- NCT number
- NCT01592773
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 747 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
- 2015-02-16
- Results first posted
- 2015-02-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With Any Treatment-emergent Adverse Event | Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit | Number of patients who experienced 1 or more Treatment Emergent Adverse Event |
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 | Patients With Any Treatment-emergent Adverse Event | Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit | Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients With Any Treatment-emergent Adverse Event | Memantine | 424 | 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 | 747 | |
| Overall Study | COMPLETED | Memantine | 81 | |
| Overall Study | NOT COMPLETED | Memantine | 666 |
Source ClinicalTrials.gov
Adverse events15
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 | Vomiting | Gastrointestinal disorders | Memantine | 51 | 747 | |
| other | Pyrexia | General disorders | Memantine | 47 | 747 | |
| other | Nasopharyngitis | Infections and infestations | Memantine | 55 | 747 | |
| other | Headache | Nervous system disorders | Memantine | 41 | 747 | |
| serious | Abdominal pain | Gastrointestinal disorders | Memantine | 1 | 747 | |
| serious | Abdominal pain lower | Gastrointestinal disorders | Memantine | 1 | 747 | |
| serious | Abnormal behaviour | Nervous system disorders | Memantine | 1 | 747 | |
| serious | Appendicitis | Infections and infestations | Memantine | 1 | 747 | |
| serious | Dehydration | Investigations | Memantine | 1 | 747 | |
| serious | Dysphoria | Nervous system disorders | Memantine | 1 | 747 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Memantine | ||
| Total, other adverse events | Memantine | 150 | 747 |
| Total, serious adverse events | Memantine | 8 | 747 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36006807 | DERIVED |
Source PubMed
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/NCT01592773
GET https://conductscience.org/api/trials/v1/NCT01592773/registered