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Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706523
Recruitment Status : Terminated
First Posted : October 15, 2012
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: STX209 (arbaclofen) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: STX209
Active treatment with STX209
 Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of STX209 [ Time Frame: 100 weeks ]
    Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments


Secondary Outcome Measures :
  1. Aberrant Behavior Checklist [ Time Frame: 100 weeks ]
    Open-label assessment of change from baseline on the ABC


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706523


Locations
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Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
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Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
More Information
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Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01706523    
Other Study ID Numbers: 209AS209
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by Seaside Therapeutics, Inc.:
Autism Spectrum Disorders
Autism
Asperger
Pervasive Developmental Disorder - Not otherwise specified
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
 Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders