Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
- Conditions
- Autism Spectrum Disorders
- Interventions
- Drug: STX209 (arbaclofen)
- Registration Number
- NCT01706523
- Lead Sponsor
- Seaside Therapeutics, Inc.
- Brief Summary
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
- Detailed Description
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "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."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
2. Provide supporting pharmacokinetic analyses
3. Assess long term efficacy on social behaviors in subjects with ASD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 165
- Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
- Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
- Treatment with no more than 2 psychoactive medications
- Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
- For female subjects, negative pregnancy test
- Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
- Current use of illicit drugs or alcohol abuse.
- Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
- Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STX209 STX209 (arbaclofen) Active treatment with STX209
- Primary Outcome Measures
Name Time Method Safety and tolerability of STX209 100 weeks Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
- Secondary Outcome Measures
Name Time Method Aberrant Behavior Checklist 100 weeks Open-label assessment of change from baseline on the ABC
Trial Locations
- Locations (25)
University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders
🇺🇸Columbia, Missouri, United States
Red Oaks Psychiatry Associates, P.A.
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Seaver Autism Center, Mount Sinai Medical Center
🇺🇸New York, New York, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Southwest Autism Research & Resource Center
🇺🇸Phoenix, Arizona, United States
Kennedy Krieger Institute
🇺🇸Baltimore, Maryland, United States
NYS Institute for Basic Research in Developmental Disabilities
🇺🇸Staten Island, New York, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Institute for Behavioral Medicine
🇺🇸Smyrna, Georgia, United States
University of California-Los Angeles Neuropsychiatric Institute
🇺🇸Los Angeles, California, United States
Institute for Juvenile Research
🇺🇸Chicago, Illinois, United States
Lake Mary Pediatrics
🇺🇸Orange City, Florida, United States
UCDavis M.I.N.D Insitute
🇺🇸Sacramento, California, United States
UNC Chapel Hill Department of Psychiatry
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Kennedy Center
🇺🇸Nashville, Tennessee, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Road Runner Research
🇺🇸San Antonio, Texas, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
University of Tennessee Medical Group, LeBonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Cutting Edge Research
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Network
🇺🇸Portland, Oregon, United States