Biomarker and DNA Collection in Subjects Participating in Protocol 22003

NCT00892580 | Completed

• 1 other identifier: 22003A
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 8

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.

Conditions

Fragile X Syndrome

Keywords

fragile X syndrome; biomarkers

Outcome Measures

Primary Outcomes (1)

• Biomarker

  evaluation of DNA for ASD to elucidate a potential biomaker

  june 2013

Interventions

STX209 DRUG

collection of serum for DNA to elucidate a potential biomarker for patients with ASD

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Autism Spectrum Disorder subjects

Sponsors & Collaborators

• Seaside Therapeutics, Inc.: lead

Study Sites (8)

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

Location

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Vanderbilt Kennedy Center

Nashville, Tennessee, 37203, United States

Location

Red Oaks Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood, plasma

MeSH Terms

Conditions

Fragile X Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Study Officials

• Craig Erikson, MD

  Riley Hospital for Children

  PRINCIPAL INVESTIGATOR

• Bryan King, MD, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• James McCracken, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Lawrence Scahill, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Linmarie Sikich, MD

  University of North Carolina Neurosciences Hospital

  PRINCIPAL INVESTIGATOR

• Jeremy Veenstra-VanderWeele, MD

  Vanderbilt Kennedy Center

  PRINCIPAL INVESTIGATOR

• Lawrence Ginsberg, MD

  Red Oaks Psychiatry Associates, PA

  PRINCIPAL INVESTIGATOR

• Raun Melmed, MD

  Southwest Autism Research & Resource Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

US (8)