Cooperative Huntington's Observational Research Trial

Huntington Disease Clinical Trial

Official title:

Cooperative Huntington's Observational Research Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00313495
• Other study ID #: COHORT
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2006
• Last updated: March 4, 2011
• Start date: February 2006
• Est. completion date: December 2020

Study information

• Verified date: March 2011
• Source: HP Therapeutics Foundation
• Contact: Huntington Study Group
• Phone: 800-487-7671
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

Description:

COHORT (Cooperative Huntington Observational Research Trial) is a coordinated research effort by Huntington Study Group research centers worldwide to prospectively collect data from consenting individuals who are affected by Huntington's disease (HD) and who are part of an HD family. The systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. The knowledge from these relationships will better inform us about the onset and progression of HD, help identify potential interventions for HD, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of HD. The consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of HD. Identification of biomarkers will in turn contribute to our understanding of HD and enhance the efficiency and power of disease-modifying therapeutic trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.

• (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.

• (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD

• (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD

• (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.

Exclusion Criteria:

• (1) Anyone who does not fit the inclusion criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Huntington Disease

Locations

Country	Name	City	State
Australia	The University of Melbourne	Kew	Victoria
Australia	Graylands, Selby-Lemnos & Special Care Health Services	Perth	Western Australia
Australia	Westmead Hospital	Wentworthville	New South Wales
Canada	University of Calgary Medical Clinic	Calgary	Alberta
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	The Centre for Addiction and Mental Health	Markham	Ontario
Canada	Hotel-Dieu Hospital-CHUM	Montreal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Movement Disorder Clinic Deer Lodge Centre	Winnipeg	Manitoba
Canada	Movement Disorders Clinic, Deer Lodge Centre	Winnipeg	Manitoba
United States	Albany Medical College	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Connecticut	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Booth Gardner Parkinsons Center	Kirkland	Washington
United States	Colorado Neurological Institute	Littleton	Colorado
United States	UCLA School of Medicine	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Tennessee-Memphis	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Institutue for Neurodegenerative Disorders	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of California, Davis	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida
United States	Hereditary Neurological Disease Center	Wichita	Kansas
United States	Wake Forest University Baptist Medical Center	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
HP Therapeutics Foundation	Huntington Study Group

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

External Links

•   The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD.