Clinical trial NCT00892580: Biomarker and DNA Collection in Subjects Participating in Protocol 22003
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
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: 2009-05-04
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Autism Spectrum Disorder subjects

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biomarker
timeFrame: june 2013
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: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina Neurosciences Hospital
state: North Carolina
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: 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: Yale University
name: Lawrence Scahill, 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: Red Oaks Psychiatry Associates, PA
name: Lawrence Ginsberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Autism Research & Resource Center
name: Raun Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References: