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NCT04271332 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion
A Phase 2 study of 16P11.2 Deletion Syndrome, sponsored by Clinical Research Associates.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT04271332 is a Phase 2 study of 16P11.2 Deletion Syndrome that is active but no longer recruiting, run by Clinical Research Associates. The registered enrollment target is 60 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT04271332, a Phase 2 study of 16P11.2 Deletion Syndrome, is active but no longer recruiting, sponsored by Clinical Research Associates.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
This Phase 2 study examines the safety, tolerability, and efficacy of arbaclofen in pediatric subjects with 16p11.2 deletion. Male or female subjects aged 5 to 17 years of age will be randomized to receive either placebo or arbaclofen in a double-blind study design. If the subject completes all study requirements through Visit 4 (Close-out Visit), he/she may be eligible for an optional open-label study with arbaclofen.
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Arbaclofen
Study Locations (4)
Massachusetts
- Boston Children's Hospital - Boston
New York
- New York State Psychiatric Institute (NYSPI) - New York
Texas
- Texas Children's Hospital - Houston
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2025-03-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04271332
The ClinicalTrials.gov registry entry for NCT04271332 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clinical Research Associates, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with 16P11.2 Deletion Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04271332 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT04271332 about?
NCT04271332 is a clinical study titled "Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion". This Phase 2 study examines the safety, tolerability, and efficacy of arbaclofen in pediatric subjects with 16p11.2 deletion. Male or female subjects aged 5 to 17 years of age will be randomized to receive either placebo or arbaclofen in a double-blind study design. If the subject completes all stud...
What is the current status of trial NCT04271332?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2022-09-01. Estimated completion is 2025-03-23.
What conditions does trial NCT04271332 study?
This clinical trial studies the following conditions: 16P11.2 Deletion Syndrome.
What interventions are being tested in trial NCT04271332?
The interventions under investigation include: Placebo oral tablet (DRUG), Arbaclofen (DRUG).
Who is sponsoring clinical trial NCT04271332?
This trial is sponsored by Clinical Research Associates, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04271332 being conducted?
This trial has 4 study locations across Massachusetts, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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