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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01706523
First received: October 10, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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:

U.S. FDA Resources

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: December 2013
Estimated Primary Completion Date: May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706523

  Show 25 Study Locations
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: October 10, 2012
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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013