A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome

Seaside Therapeutics, Inc.28 sites in 1 country172 target enrollmentJune 2011

ConditionsFragile X Syndrome

Interventionsarbaclofen Placebo

Drugsarbaclofen Placebo

Overview

Phase: Phase 3
Intervention: arbaclofen
Conditions: Fragile X Syndrome
Sponsor: Seaside Therapeutics, Inc.
Enrollment: 172
Locations: 28
Primary Endpoint: Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seaside Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Molecular documentation of the full FMR1 mutation
•Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
•Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
•If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

Exclusion Criteria

•Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
•Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
•Subjects who have taken another investigational drug within the last 30 days.
•Subjects who are not able to take oral medications