NCT00823368

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

January 13, 2009

Last Update Submit

July 30, 2013

Conditions

Fragile X Syndrome

Keywords

fragile X syndromebiomarkers

Outcome Measures

Primary Outcomes (1)

  • change in plasma proteins with treatment

    After 4 weeks of treatment

Study Arms (2)

Arbaclofen followed by Placebo

Drug: STX209

Placebo followed by Arbaclofen

Drug: STX209

Interventions

STX209DRUG
Arbaclofen followed by PlaceboPlacebo followed by Arbaclofen

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States

Location

University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

M.I.N.D. Institute

Sacramento, California, 95817, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

NYS Institute for Basic Research in Developmental Disabilities

Staten Island, New York, 10314, United States

Location

University of North Carolina Neurosciences Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Vanderbilt Kennedy Center

Nashville, Tennessee, 37203, United States

Location

Red Oaks Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood,plasma

MeSH Terms

Conditions

Fragile X Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous System

Study Officials

  • 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

    Boston 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

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(11)