Clinical trial NCT00823368: Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fragile X Syndrome
Keywords: fragile X syndrome
biomarkers
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Brief 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 criteria: 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

Primary outcomes:
measure: change in plasma proteins with treatment
timeFrame: After 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research & Resource Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: Sacramento
country: United States
facility: M.I.N.D. Institute
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Staten Island
country: United States
facility: NYS Institute for Basic Research in Developmental Disabilities
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Neurosciences Hospital
state: North Carolina
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Kennedy Center
state: Tennessee
city: Houston
country: United States
facility: Red Oaks Psychiatry Associates, PA
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Rush University Medical Center
name: Elizabeth Berry-Kravis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.I.N.D. Institute
name: Randi Hagerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riley Hospital for Children
name: Craig Erikson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Bryan King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: James McCracken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Jonathan Picker, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Neurosciences Hospital
name: Linmarie Sikich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Kennedy Center
name: Jeremy Veenstra-VanderWeele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYS Institute for Basic Research in Developmental Disabilities
name: Ted Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Red Oaks Psychiatry Associates, PA
name: Lawrence Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suburban Research Associates
name: Shivkumar Hatti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Autism Research & Resource Center
name: Raun Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References: