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Trial record 1 of 15 for:    STX209
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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.

Tracking Information
First Submitted Date  ICMJE October 10, 2012
First Posted Date  ICMJE October 15, 2012
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Safety and tolerability of STX209 [ Time Frame: 100 weeks ]
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Aberrant Behavior Checklist [ Time Frame: 100 weeks ]
Open-label assessment of change from baseline on the ABC
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
Official Title  ICMJE An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Study Arms  ICMJE Experimental: STX209
Active treatment with STX209
Intervention: Drug: STX209 (arbaclofen)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01706523
Other Study ID Numbers  ICMJE 209AS209
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seaside Therapeutics, Inc.
Study Sponsor  ICMJE Seaside Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
PRS Account Seaside Therapeutics, Inc.
Verification Date July 2013

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