Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
NCT ID: NCT00846547
Last Updated: 2013-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2009-02-28
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arbaclofen
Arbaclofen
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Interventions
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Arbaclofen
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Autistic spectrum disorders
* Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
* An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
* 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 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
Exclusion Criteria
* Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
* Subjects with any medical condition, including alcohol and drug abuse that 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 currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
* Subjects currently treated with vigabatrin or tiagabine.
* Subjects taking another investigational drug currently or within the last 30 days.
* Subjects who have a history of hypersensitivity to racemic baclofen.
6 Years
17 Years
ALL
No
Sponsors
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Seaside Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Scahill, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Craig Erikson, MD
Role: PRINCIPAL_INVESTIGATOR
Riley Hospital for Children
Bryan King, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
James McCracken, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Linmarie Sikich, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina Neurosciences Hospital
Jeremy Veenstra-VanderWeele, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Kennedy Center
Lawrence Ginsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Red Oaks Psychiatry Associates, PA
Raun Melmed, MD
Role: PRINCIPAL_INVESTIGATOR
Southwest Autism Research & Resource Center
Locations
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Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States
Yale Child Study Center
New Haven, Connecticut, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, United States
Red Oaks Psychiatry Associates, PA
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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22003
Identifier Type: -
Identifier Source: org_study_id
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