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

NCT04271332 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-30

No results posted yet for this 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

  • 16P11.2 Deletion Syndrome

Interventions

DRUG

Arbaclofen

Arbaclofen tablet

DRUG

Placebo oral tablet

Manufactured to match Arbaclofen in size, shape, color and taste

Sponsors & Collaborators

  • Clinical Research Associates, LLC

    lead OTHER

Principal Investigators

  • Paul Wang, MD · Clinical Research Associates, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-12-22
Completion
2025-03-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271332 on ClinicalTrials.gov