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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

October 10, 2012
July 30, 2013
November 2011
July 2013   (final data collection date for primary outcome measure)
Safety and tolerability of STX209 [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
Same as current
Complete list of historical versions of study NCT01706523 on ClinicalTrials.gov Archive Site
Aberrant Behavior Checklist [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]
Open-label assessment of change from baseline on the ABC
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism Spectrum Disorders
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Experimental: STX209
Active treatment with STX209
Intervention: Drug: STX209 (arbaclofen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
165
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01706523
209AS209
Yes
Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
Not Provided
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP