Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
- Registration Number
- NCT00823368
- Lead Sponsor
- Seaside Therapeutics, Inc.
- Brief Summary
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
- Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo followed by Arbaclofen STX209 - Arbaclofen followed by Placebo STX209 -
- Primary Outcome Measures
Name Time Method change in plasma proteins with treatment After 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
NYS Institute for Basic Research in Developmental Disabilities
🇺🇸Staten Island, New York, United States
Southwest Autism Research & Resource Center
🇺🇸Phoenix, Arizona, United States
M.I.N.D. Institute
🇺🇸Sacramento, California, United States
University of North Carolina Neurosciences Hospital
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt Kennedy Center
🇺🇸Nashville, Tennessee, United States
Red Oaks Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
University of California-Los Angeles Neuropsychiatric Institute
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States