Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Completed

• Conditions: Fragile X Syndrome

• Registration Number: NCT00892580
• Lead Sponsor: Seaside Therapeutics, Inc.

Brief Summary

The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003 will be offered participation in 22003A 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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2010-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003

Exclusion Criteria

• The Autism Spectrum Disorder subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarker	june 2013	evaluation of DNA for ASD to elucidate a potential biomaker

Trial Locations

Locations (8)

Southwest Autism Research & Resource Center; 🇺🇸 Phoenix, Arizona, United States

University of California-Los Angeles Neuropsychiatric Institute; 🇺🇸 Los Angeles, California, United States

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, 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

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States