Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00846547
First received: February 17, 2009
Last updated: May 10, 2013
Last verified: May 2013

February 17, 2009
May 10, 2013
February 2009
June 2010   (final data collection date for primary outcome measure)
Irritability Subscale of the Aberrant Behavior Checklist, Community Version [ Time Frame: At 8 weeks during the treatment period ] [ Designated as safety issue: No ]
The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).
  • Irritability Subscale of the Aberrant Behavior Checklist, Community Version [ Time Frame: At 2, 4, 6, and 8 weeks during the treatment period ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: During the course of the study and for 30 days after the end of the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00846547 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders
An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders

The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism Spectrum Disorders
Drug: Arbaclofen
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
Other Name: STX209
Experimental: Arbaclofen
Intervention: Drug: Arbaclofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects 6 to 17 years of age, inclusive.
  • Diagnosis of Autistic spectrum disorders
  • Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
  • An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
  • If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
  • Exclusion Criteria:
  • Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
  • Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
  • Subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
  • Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
  • Subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
  • Subjects currently treated with vigabatrin or tiagabine.
  • Subjects taking another investigational drug currently or within the last 30 days.
  • Subjects who have a history of hypersensitivity to racemic baclofen.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846547
22003
Yes
Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
Not Provided
Principal Investigator: Lawrence Scahill, PhD Yale University
Principal Investigator: Craig Erikson, MD Riley Hospital for Children
Principal Investigator: Bryan King, MD, PhD Seattle Children's Hospital
Principal Investigator: James McCracken, MD University of California, Los Angeles
Principal Investigator: Linmarie Sikich, MD University of North Carolina Neurosciences Hospital
Principal Investigator: Jeremy Veenstra-VanderWeele, MD Vanderbilt Kennedy Center
Principal Investigator: Lawrence Ginsberg, MD Red Oaks Psychiatry Associates, PA
Principal Investigator: Raun Melmed, MD Southwest Autism Research & Resource Center
Seaside Therapeutics, Inc.
May 2013

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