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

Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 40
Healthy Volunteers: No
View:

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

Locations
United States
Arizona
Southwest Autism Research & Resource Center
Phoenix
California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles
M.I.N.D. Institute
Sacramento
Illinois
Rush University Medical Center
Chicago
Indiana
Riley Hospital for Children
Indianapolis
North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill
New York
NYS Institute for Basic Research in Developmental Disabilities
Staten Island
Pennsylvania
Suburban Research Associates
Media
Tennessee
Vanderbilt Kennedy Center
Nashville
Texas
Red Oaks Psychiatry Associates, PA
Houston
Washington
Seattle Children's Hospital
Seattle
Time Frame
Start Date: January 2009
Completion Date: March 2010
Treatments
Arbaclofen followed by Placebo
Placebo followed by Arbaclofen
Authors
Raun Melmed, Jonathan Picker, Lawrence Ginsberg, Bryan King, Shivkumar Hatti, Linmarie Sikich, Jeremy Veenstra-VanderWeele, James McCracken, Randi Hagerman, Craig Erikson, Ted Brown, Elizabeth Berry-Kravis
Related Therapeutic Areas
Sponsors
Leads: Seaside Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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