Autism Spectrum Disorders
Conditions
Keywords
Autism Spectrum Disorders, Autism, Asperger, Pervasive Developmental Disorder - Not otherwise specified
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.
Interventions
DRUGSTX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Sponsors
Seaside Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of STX209 | 100 weeks | Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aberrant Behavior Checklist | 100 weeks | Open-label assessment of change from baseline on the ABC |
Countries
United States
Outcome results
None listed