Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
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
1 other identifier
interventional
150
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 31, 2013
July 1, 2013
1.3 years
January 31, 2011
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Aberrant Behavior Checklist-Social Withdrawal Subscale
At 8 weeks of treatment
Study Arms (2)
Placebo
PLACEBO COMPARATORArbaclofen
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006, United States
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024, United States
University of California-Davis, M.I.N.D. Institute
Sacramento, California, 95817, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Lake Mary Pediatrics
Orange City, Florida, 32763, United States
Institute for Behavioral Medicine
Smyrna, Georgia, 30080, United States
Institute for Juvenile Research
Chicago, Illinois, 60608, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts
Worcester, Massachusetts, 01605, United States
University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders
Columbia, Missouri, 65211, United States
Seaver Autism Center, Mount Sinai Medical Center
New York, New York, 10029, United States
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, 27514, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Summit Research Network
Portland, Oregon, 97210, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Tennessee Medical Group, LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, 37203, United States
Red Oaks Psychiatry Associates, P.A.
Houston, Texas, 77090, United States
Road Runner Research
San Antonio, Texas, 78258, United States
Seattle Children's Hospital
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 2, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
July 31, 2013
Record last verified: 2013-07