Trial · NCT01999894
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
NCT01999894, Phase 2, Completed, Forest Laboratories; results first posted 2014-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Study of Safety and Tolerability of Memantine in Children With Autism. Trials, record NCT01999894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of Safety and Tolerability of Memantine in Children With Autism
- NCT number
- NCT01999894
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Autism, Pediatric Autism
- Interventions
- Memantine HCl
- First posted
- 2013-12-03
- Last updated
- 2014-03-18
- Results first posted
- 2014-03-18
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 Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48) | Number of patients who experienced one or more TEAEs during the study |
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 Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48) | The Safety Population consists of 102 enrolled patients who received at least one dose of study drug. | 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 |
|---|---|---|---|---|---|
| Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | Memantine | 85 | 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 | 102 | |
| Overall Study | COMPLETED | Memantine | 66 | |
| Overall Study | NOT COMPLETED | Memantine | 36 |
Source ClinicalTrials.gov
Adverse events48
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 | Constipation | Gastrointestinal disorders | Placebo to Memantine | 5 | 50 | |
| other | Constipation | Gastrointestinal disorders | Memantine to Memantine | 2 | 52 | |
| other | Vomiting | Gastrointestinal disorders | Placebo to Memantine | 6 | 50 | |
| other | Vomiting | Gastrointestinal disorders | Memantine to Memantine | 2 | 52 | |
| other | Irritability | General disorders | Placebo to Memantine | 2 | 50 | |
| other | Irritability | General disorders | Memantine to Memantine | 5 | 52 | |
| other | Pyrexia | General disorders | Placebo to Memantine | 1 | 50 | |
| other | Pyrexia | General disorders | Memantine to Memantine | 5 | 52 | |
| other | Seasonal allergy | Immune system disorders | Placebo to Memantine | 7 | 50 | |
| other | Seasonal allergy | Immune system disorders | Memantine to Memantine | 2 | 52 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo to Memantine | ||
| Total, all-cause mortality | Memantine to Memantine | ||
| Total, other adverse events | Placebo to Memantine | 37 | 50 |
| Total, other adverse events | Memantine to Memantine | 37 | 52 |
| Total, serious adverse events | Placebo to Memantine | 1 | 50 |
| Total, serious adverse events | Memantine to Memantine | 0 | 52 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Memantine to Memantine vs Placebo to Memantine: serious adverse events |
Source Trial comparisons
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/NCT01999894
GET https://conductscience.org/api/trials/v1/NCT01999894/events?page=2