NCT00892580

Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Seaside Therapeutics, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	STX209	collection of serum for DNA to elucidate a potential biomarker for patients with ASD

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-06-01
• First posted: 2009-05-04
• Last updated: 2013-07-31

Locations

8 sites across 1 country: United States