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NCT01333865 · ClinicalTrials.gov registry record · Phase 4
A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT01333865: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01333865 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333865, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficacious and well tolerated in the treatment of adults with ASD. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Primary Outcome
Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%. The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings.
Interventions
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
What the finished NCT01333865 record still lists
NCT01333865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Memantine is the first listed.
NCT01333865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01333865 about?
NCT01333865 is a clinical study titled "A Study of Memantine Hydrochloride (Namenda®) for Cognitive and Behavioral Impairment in Adults With Autism Spectrum Disorders". The main objective of this study is to evaluate the safety and effectiveness of memantine (Namenda®) for cognitive and behavioral impairment in adults ages 18-50 years with autism spectrum disorders (ASD). This is an exploratory, 12-week, pilot study, seeking to determine whether Namenda is efficaci...
What is the current status of trial NCT01333865?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2010-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01333865?
The interventions under investigation include: Memantine (DRUG).
Who is sponsoring clinical trial NCT01333865?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01333865's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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