NCT00052143

Brief Summary

The purpose of this study is to define the natural history and experiences of people who are at risk for developing Huntington's disease but who do not know their genetic status.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1999

Longer than P75 for all trials

Geographic Reach
2 countries

42 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

July 9, 1999

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2003

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2009

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

10.4 years

First QC Date

January 23, 2003

Last Update Submit

August 29, 2024

Conditions

Keywords

Huntington's diseaseHDHuntington disease

Eligibility Criteria

Age26 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HD Community

You may qualify if:

  • Men and women between 26-55 years of age;
  • Who are at risk for HD by virtue of having (or had) a parent or sibling with the illness;
  • Who have never been tested for the HD gene, and who do not desire to be tested for the HD gene during the duration of the study;
  • Agree to blinded (sample will be coded) genetic testing of the HD gene; and
  • Who have never been diagnosed with HD.

You may not qualify if:

  • Individuals Who:
  • have been diagnosed with HD;
  • are taking antipsychotic medications;
  • use antiemetic (anti-nausea) medications with on a regular basis (greater than 3 times per month); or
  • exhibit clinical signs/symptoms of psychosis at the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

University of Alabama

Birmingham, Alabama, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, United States

Location

University of California at San Diego

La Jolla, California, United States

Location

UCLA School of Medicine

Los Angeles, California, United States

Location

University of California, Davis

Sacramento, California, United States

Location

Colorado Neurological Institute

Englewood, Colorado, United States

Location

University of Connecticut

Hartford, Connecticut, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Location

University of Miami School of Medicine

Miami, Florida, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, United States

Location

Hereditary Neurological Disease Center

Wichita, Kansas, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

University of Maryland at Baltimore

Baltimore, Maryland, United States

Location

Boston University School of Medicine

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

UMDNJ Huntington Disease Service Center

Stratford, New Jersey, United States

Location

Albany Medical College

Albany, New York, United States

Location

North Shore-LIJ Health System

Manhasset, New York, United States

Location

Columbia University

New York, New York, United States

Location

University of Rochester

Rochester, New York, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

NeuroHealth Parkinson's Disease Movement Disorders Center

Pawtucket, Rhode Island, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

University of Washington and VA Puget Sound

Seattle, Washington, United States

Location

Medical College of Wisconsin-Milwaukee

Milwaukee, Wisconsin, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

The Centre for Addiction and Mental Health

Markham, Ontario, Canada

Location

Hotel-Dieu Hospital-CHUM

Montreal, Quebec, Canada

Location

Related Publications (2)

  • Huntington Study Group PHAROS Investigators. At risk for Huntington disease: The PHAROS (Prospective Huntington At Risk Observational Study) cohort enrolled. Arch Neurol. 2006 Jul;63(7):991-6. doi: 10.1001/archneur.63.7.991.

    PMID: 16831969BACKGROUND
  • Oster E, Dorsey ER, Bausch J, Shinaman A, Kayson E, Oakes D, Shoulson I, Quaid K; Huntington Study Group PHAROS Investigators. Fear of health insurance loss among individuals at risk for Huntington disease. Am J Med Genet A. 2008 Aug 15;146A(16):2070-7. doi: 10.1002/ajmg.a.32422.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Ira Shoulson, M.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2003

First Posted

January 24, 2003

Study Start

July 9, 1999

Primary Completion

December 17, 2009

Study Completion

December 17, 2009

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations