STX209 (R-baclofen) for Children with Autism Spectrum Disorders

Purpose

This study is sponsored by Seaside Therapeutics and is being conducted by six research centers in the U.S. (Yale University, University of California, Los Angeles, Indiana University, University of North Carolina, Vanderbilt University and Seattle Children's Hospital). The purpose of the study is evaluate whether an experimental medicine, STX209 (R-baclofen), is safe and effective for the treatment of irritability in children with Autism or PDD-NOS.
Eligible children will be offered up to 8 weeks of treatment with R-baclofen. During the treatment period, children will be monitored closely for side effects and will meet with the study doctor every 2 weeks. Between office visits, parents will also receive up to 4 phone calls from the study doctor. At the end of the 8-week treatment period, the medication will be gradually withdrawn over a 2-week period.
Participation in this study will last up to 18 weeks and requires up to 8 visits to the Child Study Center and 17 phone calls with the study doctor. For each visit to the Center, a small payment will be offered to offset travel expenses. The study medication and all study-related evaluations are provided free of charge.

Criteria for participation

• Males or females between 6 and 17 years of age
• Diagnosis of Autistic Disorder or PDD-NOS
• Serious behavioral problems such as aggression, tantrums, or self-injury
• Not taking medication for these symptoms or willing to withdraw an ineffective medication currently being taken for these symptoms

Contacts

Allison Gavaletz
(203) 785-6669
allison.gavaletz@yale.edu

HIC#0811004482