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

Autism Spectrum Disorders Clinical Trial

Official title:

An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01706523
• Other study ID #: 209AS209
• Status: Terminated
• Phase: Phase 3
• First received: October 10, 2012
• Last updated: July 30, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: July 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

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety 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
• Disease

Intervention

Drug:
• STX209 (arbaclofen)
Long-term, daily, orally-administered STX209

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	UNC Chapel Hill Department of Psychiatry	Chapel Hill	North Carolina
United States	Institute for Juvenile Research	Chicago	Illinois
United States	University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders	Columbia	Missouri
United States	Red Oaks Psychiatry Associates, P.A.	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of California-Los Angeles Neuropsychiatric Institute	Los Angeles	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	University of Tennessee Medical Group, LeBonheur Children's Hospital	Memphis	Tennessee
United States	Pharmax Research Clinic	Miami	Florida
United States	Vanderbilt Kennedy Center	Nashville	Tennessee
United States	Seaver Autism Center, Mount Sinai Medical Center	New York	New York
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	Lake Mary Pediatrics	Orange City	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona
United States	Summit Research Network	Portland	Oregon
United States	UCDavis M.I.N.D Insitute	Sacramento	California
United States	Road Runner Research	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	NYS Institute for Basic Research in Developmental Disabilities	Staten Island	New York
United States	University of Massachusetts	Worcester	Massachusetts

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	Safety and tolerability of STX209	Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments	100 weeks	Yes
Secondary	Aberrant Behavior Checklist	Open-label assessment of change from baseline on the ABC	100 weeks	Yes