Trial record 1 of 252 for:    209as209
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Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01706523
First received: October 10, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorders
Drug: STX209 (arbaclofen)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of STX209 [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]
    Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments


Secondary Outcome Measures:
  • Aberrant Behavior Checklist [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]
    Open-label assessment of change from baseline on the ABC


Estimated Enrollment: 165
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STX209
Active treatment with STX209
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209

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.
  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706523

  Hide Study Locations
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
UCDavis M.I.N.D Insitute
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 & Neurodevelopmental Disorders
Columbia, Missouri, United States, 65211
United States, New York
Seaver Autism Center, Mount Sinai Medical Center
New York, New York, United States, 10029
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, United States, 10314
United States, North Carolina
UNC Chapel Hill Department of Psychiatry
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.
Investigators
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01706523     History of Changes
Other Study ID Numbers: 209AS209
Study First Received: October 10, 2012
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seaside Therapeutics, Inc.:
Autism Spectrum Disorders
Autism
Asperger
Pervasive Developmental Disorder - Not otherwise specified

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014