Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders - Full Text View

Purpose

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

Condition	Intervention	Phase
Autism Spectrum Disorders	Drug: Arbaclofen	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: Asperger syndrome

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:

Aberrant Behavior Checklist-Social Withdrawal Subscale [ Time Frame: At 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Arbaclofen orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 10 mg dose	Drug: Arbaclofen orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 20 mg dose	Drug: Arbaclofen orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 30 mg dose	Drug: Arbaclofen orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid Other Name: STX209, R-baclofen
Active Comparator: Arbaclofen 45 mg dose	Drug: Arbaclofen orally disintegrating tablet (ODT) 5 mg bid, 10 mg bid, 10 mg tid and 15 mg tid Other Name: STX209, R-baclofen

Eligibility

Ages Eligible for Study:	5 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288716

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Locations

United States, Arizona
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
United States, California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
University of California-Davis, M.I.N.D. Institute
Sacramento, California, United States, 95817
United States, Florida
Pharmax Research Clinic
Miami, Florida, United States, 33126
Lake Mary Pediatrics
Orange City, Florida, United States, 32763
United States, Georgia
Institute for Behavioral Medicine
Smyrna, Georgia, United States, 30080
United States, Illinois
Institute for Juvenile Research
Chicago, Illinois, United States, 60608
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
University of Massachusetts
Worcester, Massachusetts, United States, 01605
United States, Missouri
University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders
Columbia, Missouri, United States, 65211
United States, New York
Seaver Autism Center, Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
United States, Oklahoma
Cutting Edge Research
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
University of Tennessee Medical Group, LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Vanderbilt Kennedy Center
Nashville, Tennessee, United States, 37203
United States, Texas
Red Oaks Psychiatry Associates, P.A.
Houston, Texas, United States, 77090
Road Runner Research
San Antonio, Texas, United States, 78258
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Seaside Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Randall Carpenter, MD, CEO, Seaside Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT01288716 History of Changes
Other Study ID Numbers:	209AS208
Study First Received:	January 31, 2011
Last Updated:	June 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seaside Therapeutics, Inc.:

ASD
Autism
Asperger Syndrome

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013