Biomarker and DNA Collection in Subjects Participating in Protocol 22003

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00892580
First received: May 1, 2009
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Fragile X Syndrome
Drug: STX209

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:
  • Biomarker [ Time Frame: june 2013 ] [ Designated as safety issue: No ]
    evaluation of DNA for ASD to elucidate a potential biomaker


Biospecimen Retention:   Samples With DNA

DNA from blood, plasma


Enrollment: 32
Study Start Date: May 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: STX209
    collection of serum for DNA to elucidate a potential biomarker for patients with ASD
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Autism Spectrum Disorder subjects

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892580

Locations
United States, Arizona
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
United States, California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States, 27514
United States, Tennessee
Vanderbilt Kennedy Center
Nashville, Tennessee, United States, 37203
United States, Texas
Red Oaks Psychiatry Associates, PA
Houston, Texas, United States, 77090
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00892580     History of Changes
Other Study ID Numbers: 22003A
Study First Received: May 1, 2009
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seaside Therapeutics, Inc.:
fragile X syndrome
biomarkers

Additional relevant MeSH terms:
Syndrome
Fragile X Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on October 16, 2014