Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Phase 2

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Drug: Arbaclofen

• Registration Number: NCT01288716
• Lead Sponsor: Seaside Therapeutics, Inc.

Brief Summary

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis of Autism Spectrum Disorders (ASD)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arbaclofen	Arbaclofen	-

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist-Social Withdrawal Subscale	At 8 weeks of treatment

Trial Locations

Locations (24)

Southwest Autism Research & Resource Center; 🇺🇸 Phoenix, Arizona, United States

University of California-Los Angeles Neuropsychiatric Institute; 🇺🇸 Los Angeles, California, United States

University of California-Davis, M.I.N.D. Institute; 🇺🇸 Sacramento, California, United States

Pharmax Research Clinic; 🇺🇸 Miami, Florida, United States

Lake Mary Pediatrics; 🇺🇸 Orange City, Florida, United States

Institute for Behavioral Medicine; 🇺🇸 Smyrna, Georgia, United States

Institute for Juvenile Research; 🇺🇸 Chicago, Illinois, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

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