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Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

NCT ID: NCT00823368

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fragile X Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arbaclofen followed by Placebo

STX209

Intervention Type DRUG

Placebo followed by Arbaclofen

STX209

Intervention Type DRUG

Interventions

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STX209

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seaside Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Berry-Kravis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Randi Hagerman, MD

Role: PRINCIPAL_INVESTIGATOR

M.I.N.D. Institute

Craig Erikson, MD

Role: PRINCIPAL_INVESTIGATOR

Riley Hospital for Children

Bryan King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

James McCracken, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Jonathan Picker, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Linmarie Sikich, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Neurosciences Hospital

Jeremy Veenstra-VanderWeele, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Kennedy Center

Ted Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYS Institute for Basic Research in Developmental Disabilities

Lawrence Ginsberg, MD

Role: PRINCIPAL_INVESTIGATOR

Red Oaks Psychiatry Associates, PA

Shivkumar Hatti, MD

Role: PRINCIPAL_INVESTIGATOR

Suburban Research Associates

Raun Melmed, MD

Role: PRINCIPAL_INVESTIGATOR

Southwest Autism Research & Resource Center

Locations

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Southwest Autism Research & Resource Center

Phoenix, Arizona, United States

Site Status

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, United States

Site Status

M.I.N.D. Institute

Sacramento, California, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

NYS Institute for Basic Research in Developmental Disabilities

Staten Island, New York, United States

Site Status

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

Vanderbilt Kennedy Center

Nashville, Tennessee, United States

Site Status

Red Oaks Psychiatry Associates, PA

Houston, Texas, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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22001A

Identifier Type: -

Identifier Source: org_study_id

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