Autism Spectrum Disorders
Conditions
Keywords
ASD, Autism, Asperger Syndrome
Brief summary
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders
Interventions
DRUGArbaclofen
Sponsors
Seaside Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Autism Spectrum Disorders (ASD) * Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. * Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. * 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 2 months prior to Screening
Exclusion criteria
* Subjects with any condition, including alcohol and drug abuse, which 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 who have taken another investigational drug within the last 30 days. * Subjects who are not able to take oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aberrant Behavior Checklist-Social Withdrawal Subscale | At 8 weeks of treatment |
Countries
United States
Outcome results
None listed