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

Study Overview
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Brief Summary
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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
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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: Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen) Provide supporting pharmacokinetic analyses Assess long term efficacy on social behaviors in subjects with ASD.

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

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Drug: STX209 (arbaclofen)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STX209<br>Active treatment with STX209 | Drug: STX209 (arbaclofen)<br>* Long-term, daily, orally-administered STX209<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of STX209 | Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments | 100 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist | Open-label assessment of change from baseline on the ABC | 100 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified