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NCT01972074 · ClinicalTrials.gov registry record · Phase 3
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT01972074: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT01972074 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 84 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972074, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\] and hydrogen magnetic resonance spectroscopy \[HMRS\]) to assess neural functional deficits in adolescents with autism spectrum disorder compared to healthy volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any effects of memantine therapy on neural function in adolescents with autism spectrum disorder. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in adolescents with autism spectrum disorder. Additionally, the investigators hypothesize that following memantine therapy, adolescents with autism spectrum disorder will exhibit a decrease in glutamate (Glu) concentration in the anterior cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the anterior cingulate cortex and medial temporal lobes, consistent with improvement in social impairments in autism spectrum disorder. The investigators hypothesize that compared to healthy volunteer participants, participants with autism spectrum disorder will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between autism spectrum disorder and healthy volunteer neuroimaging data will decrease.
Interventions
- OTHER Placebo
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2015-02-17 |
| Est. Completion | 2018-05-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01972074
The ClinicalTrials.gov registry entry for NCT01972074 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01972074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01972074 about?
NCT01972074 is a clinical study titled "Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder". This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\...
What is the current status of trial NCT01972074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2015-02-17. Estimated completion is 2018-05-07.
What interventions are being tested in trial NCT01972074?
The interventions under investigation include: Placebo (OTHER), Memantine (DRUG).
Who is sponsoring clinical trial NCT01972074?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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