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Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00823368
First received: January 13, 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 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.


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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • change in plasma proteins with treatment [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA from blood,plasma


Study Start Date: January 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arbaclofen followed by Placebo Drug: STX209
Placebo followed by Arbaclofen Drug: STX209

  Eligibility

Ages Eligible for Study:   6 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  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: NCT00823368

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
M.I.N.D. Institute
Sacramento, California, United States, 95817
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, New York
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, United States, 10314
United States, North Carolina
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
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: Elizabeth Berry-Kravis, MD, PhD Rush University Medical Center
Principal Investigator: Randi Hagerman, MD M.I.N.D. Institute
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: Jonathan Picker, MBChB, PhD Children's Hospital Boston
Principal Investigator: Linmarie Sikich, MD University of North Carolina Neurosciences Hospital
Principal Investigator: Jeremy Veenstra-VanderWeele, MD Vanderbilt Kennedy Center
Principal Investigator: Ted Brown, MD, PhD NYS Institute for Basic Research in Developmental Disabilities
Principal Investigator: Lawrence Ginsberg, MD Red Oaks Psychiatry Associates, PA
Principal Investigator: Shivkumar Hatti, MD Suburban Research Associates
Principal Investigator: Raun Melmed, MD Southwest Autism Research & Resource Center
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00823368     History of Changes
Other Study ID Numbers: 22001A
Study First Received: January 13, 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:
Fragile X Syndrome
Syndrome
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Intellectual Disability
Mental Retardation, X-Linked
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Sex Chromosome Disorders

ClinicalTrials.gov processed this record on November 20, 2014