Biomarker and DNA Collection in Subjects Participating in Protocol 22003

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

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.

Study Overview

• Status: Completed
• Conditions: Fragile X Syndrome
• Intervention / Treatment: Drug: STX209

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Southwest Autism Research & Resource Center
  • California
    • Los Angeles, California, United States, 90024
      • University of California-Los Angeles Neuropsychiatric Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Child Study Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Neurosciences Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt Kennedy Center
  • Texas
    • Houston, Texas, United States, 77090
      • Red Oaks Psychiatry Associates, PA
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Autism Spectrum Disorder subjects

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker	evaluation of DNA for ASD to elucidate a potential biomaker	june 2013

Collaborators and Investigators

• Sponsor: Seaside Therapeutics, Inc.
• Investigators: Principal Investigator: James McCracken, MD, University of California, Los Angeles; Principal Investigator: Craig Erikson, MD, Riley Hospital for Children; Principal Investigator: Bryan King, MD, PhD, Seattle Children's Hospital; 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: Lawrence Scahill, PhD, Yale University

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: May 1, 2009
• First Submitted That Met QC Criteria: May 1, 2009
• First Posted (Estimate): May 4, 2009

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: biomarkers; fragile X syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Mental Retardation, X-Linked; Intellectual Disability; Heredodegenerative Disorders, Nervous System; Chromosome Disorders; Sex Chromosome Disorders; Fragile X Syndrome
• Other Study ID Numbers: 22003A