Clinical Trial: Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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 Subjec

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 Summary:
Sponsor: Seaside Therapeutics, Inc.

Current Primary Outcome: Biomarker [ Time Frame: june 2013 ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seaside Therapeutics, Inc.

Dates:
Date Received: May 1, 2009
Date Started: May 2009
Date Completion:
Last Updated: July 30, 2013
Last Verified: July 2013