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

Autism Spectrum Disorders Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288716
• Other study ID #: 209AS208
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2011
• Last updated: July 30, 2013
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: Seaside Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Arbaclofen

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of North Carolina Neurosciences Hospital	Chapel Hill	North Carolina
United States	Institute for Juvenile Research	Chicago	Illinois
United States	University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders	Columbia	Missouri
United States	Red Oaks Psychiatry Associates, P.A.	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of California-Los Angeles Neuropsychiatric Institute	Los Angeles	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	University of Tennessee Medical Group, LeBonheur Children's Hospital	Memphis	Tennessee
United States	Pharmax Research Clinic	Miami	Florida
United States	Vanderbilt Kennedy Center	Nashville	Tennessee
United States	Seaver Autism Center, Mount Sinai Medical Center	New York	New York
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	Lake Mary Pediatrics	Orange City	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona
United States	Summit Research Network	Portland	Oregon
United States	University of California-Davis, M.I.N.D. Institute	Sacramento	California
United States	Road Runner Research	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavior Checklist-Social Withdrawal Subscale		At 8 weeks of treatment	No