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ACTIVE NOT RECRUITING Phase 2

Safety, Tolerability, and Efficacy of Arbaclofen in 16p11.2 Deletion

NCT04271332 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 60 participants
Start Date 2022-09-01
Est. Completion 2025-03-23
Phase Phase 2

Sponsor

Clinical Research Associates

1 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04271332 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04271332?

The interventions under investigation include: Placebo oral tablet (DRUG), Arbaclofen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04271332?

This trial is sponsored by Clinical Research Associates, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial