Clinical trial NCT01706523: Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
Official title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders
Autism
Asperger
Pervasive Developmental Disorder - Not otherwise specified
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 165
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of STX209
timeFrame: 100 weeks
Secondary outcomes:
measure: Aberrant Behavior Checklist
timeFrame: 100 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research & Resource Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: Sacramento
country: United States
facility: UCDavis M.I.N.D Insitute
state: California
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Orange City
country: United States
facility: Lake Mary Pediatrics
state: Florida
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Chicago
country: United States
facility: Institute for Juvenile Research
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders
state: Missouri
city: New York
country: United States
facility: Seaver Autism Center, Mount Sinai Medical Center
state: New York
city: Staten Island
country: United States
facility: NYS Institute for Basic Research in Developmental Disabilities
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Department of Psychiatry
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Medical Group, LeBonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
city: Houston
country: United States
facility: Red Oaks Psychiatry Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seaside Therapeutics, Inc.
name: Paul Wang, M.D.
role: STUDY_DIRECTOR
References: