Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of 16P11.2 Deletion Syndrome, sponsored by Clinical Research Associates.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT04271332 still lists
NCT04271332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for 16P11.2 Deletion Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04271332's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI