Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
1 other identifier
interventional
165
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2011
25 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
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 31, 2013
July 1, 2013
1.7 years
October 10, 2012
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of STX209
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
100 weeks
Secondary Outcomes (1)
Aberrant Behavior Checklist
100 weeks
Study Arms (1)
STX209
EXPERIMENTALActive treatment with STX209
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006, United States
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024, United States
UCDavis M.I.N.D Insitute
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 & Neurodevelopmental Disorders
Columbia, Missouri, 65211, United States
Seaver Autism Center, Mount Sinai Medical Center
New York, New York, 10029, United States
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, 10314, United States
UNC Chapel Hill Department of Psychiatry
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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Wang, M.D.
Seaside Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 15, 2012
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 31, 2013
Record last verified: 2013-07