Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

Fragile X Syndrome Clinical Trial

Official title:

Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823368
• Other study ID #: 22001A
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: July 30, 2013
• Start date: January 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Exclusion Criteria:

• Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fragile X Syndrome

Intervention

Drug:
• STX209

Locations

Country	Name	City	State
United States	University of North Carolina Neurosciences Hospital	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
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	Suburban Research Associates	Media	Pennsylvania
United States	Vanderbilt Kennedy Center	Nashville	Tennessee
United States	Southwest Autism Research & Resource Center	Phoenix	Arizona
United States	M.I.N.D. Institute	Sacramento	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	NYS Institute for Basic Research in Developmental Disabilities	Staten Island	New York

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	change in plasma proteins with treatment		After 4 weeks of treatment	No