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Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

NCT00823368 · Status: COMPLETED · Type: OBSERVATIONAL

Last updated 2013-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

STX209

Sponsors & Collaborators

  • Seaside Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Elizabeth Berry-Kravis, MD, PhD · Rush University Medical Center

  • Randi Hagerman, MD · M.I.N.D. Institute

  • Craig Erikson, MD · Riley Hospital for Children

  • Bryan King, MD, PhD · Seattle Children's Hospital

  • James McCracken, MD · University of California, Los Angeles

  • Jonathan Picker, MBChB, PhD · Boston Children's Hospital

  • Linmarie Sikich, MD · University of North Carolina Neurosciences Hospital

  • Jeremy Veenstra-VanderWeele, MD · Vanderbilt Kennedy Center

  • Ted Brown, MD, PhD · NYS Institute for Basic Research in Developmental Disabilities

  • Lawrence Ginsberg, MD · Red Oaks Psychiatry Associates, PA

  • Shivkumar Hatti, MD · Suburban Research Associates

  • Raun Melmed, MD · Southwest Autism Research & Resource Center

Eligibility

Min Age
6 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823368 on ClinicalTrials.gov