Biomarker and DNA Collection in Subjects Participating in Protocol 22003

Fragile X Syndrome Clinical Trial

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 Subjects With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892580
• Other study ID #: 22003A
• Status: Completed
• Phase: N/A
• First received: May 1, 2009
• Last updated: July 30, 2013
• Start date: May 2009

Study information

• Verified date: July 2013
• Source: Seaside Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fragile X Syndrome

Intervention

Drug:
• STX209
collection of serum for DNA to elucidate a potential biomarker for patients with ASD

Locations

Country	Name	City	State
United States	University of North Carolina Neurosciences Hospital	Chapel Hill	North Carolina
United States	Red Oaks Psychiatry Associates, PA	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of California-Los Angeles Neuropsychiatric Institute	Los Angeles	California
United States	Vanderbilt Kennedy Center	Nashville	Tennessee
United States	Yale Child Study Center	New Haven	Connecticut
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker	evaluation of DNA for ASD to elucidate a potential biomaker	june 2013	No