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

Autism Spectrum Disorders Clinical Trial

Official title:

An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846547
• Other study ID #: 22003
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: May 10, 2013
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2013
• Source: Seaside Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Arbaclofen
variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Locations

Country	Name	City	State
United States	University of North Carolina Neurosciences Hospital	Chapel Hill	North Carolina
United States	Red Oaks Psychiatry Associates, PA	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of California-Los Angeles Neuropsychiatric Institute	Los Angeles	California
United States	Vanderbilt Kennedy Center	Nashville	Tennessee
United States	Yale Child Study Center	New Haven	Connecticut
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritability Subscale of the Aberrant Behavior Checklist, Community Version	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).	At 8 weeks during the treatment period	No