Prospective Huntington At Risk Observational Study (PHAROS)

August 29, 2024 updated by: Huntington Study Group

Prospective Huntington At Risk Observational Study (PHAROS)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Huntington's disease (HD) is a genetic disease characterized by changes in movement and behavior. To date, little research has been done on individuals who are at risk for developing the disease. PHAROS is an observational study designed to monitor people who are at risk for developing HD, and to survey their attitudes and beliefs about their "at-risk" status. Investigators hope this study will help answer some important questions about HD, such as: 1.) What are the earliest signs of HD and when do they start? 2.) How accurate are the measures that physicians use in detecting the onset of HD? 3.) What factors influence the age at which a person carrying the HD gene develops the illness? and 4.) In a group of people at risk for HD, how many will develop signs of the illness over a minimum three-year period of observation?

Participants in the study will be evaluated every 9 months (for 5 years) using the Unified Huntington's Disease Rating Scale (UHDRS)--a clinical tool which looks at movement, psychological and behavioral function. The participants will also be asked to complete surveys about their mood, life events, and attitudes or beliefs about being at risk for HD. A blood sample, taken at the beginning of the study, will be confidentially tested to determine if the participant has the abnormal gene for HD. Neither the participant nor any of the PHAROS physicians or coordinators will learn the results of individual gene tests.

The scientists hope that this study will provide essential information for future trials of experimental drugs for HD.

Study Type

Observational

Enrollment (Actual)

1001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
    • Ontario
      • Markham, Ontario, Canada
        • The Centre for Addiction and Mental Health
    • Quebec
      • Montreal, Quebec, Canada
        • Hotel-Dieu Hospital-CHUM
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States
        • Mayo Clinic Arizona
    • California
      • La Jolla, California, United States
        • University of California at San Diego
      • Los Angeles, California, United States
        • UCLA School of Medicine
      • Sacramento, California, United States
        • University of California, Davis
    • Colorado
      • Englewood, Colorado, United States
        • Colorado Neurological Institute
    • Connecticut
      • Hartford, Connecticut, United States
        • University of Connecticut
      • New Haven, Connecticut, United States
        • Institute For Neurodegenerative Disorders
    • Florida
      • Miami, Florida, United States
        • University of Miami School Of Medicine
      • Tampa, Florida, United States
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
    • Illinois
      • Chicago, Illinois, United States
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center
      • Wichita, Kansas, United States
        • Hereditary Neurological Disease Center
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University
      • Baltimore, Maryland, United States
        • University of Maryland at Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University School of Medicine
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Hennepin County Medical Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
    • New Jersey
      • Stratford, New Jersey, United States
        • UMDNJ Huntington Disease Service Center
    • New York
      • Albany, New York, United States
        • Albany Medical College
      • Manhasset, New York, United States
        • North Shore-LIJ Health System
      • New York, New York, United States
        • Columbia University
      • Rochester, New York, United States
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
    • Rhode Island
      • Pawtucket, Rhode Island, United States
        • NeuroHealth Parkinson's Disease Movement Disorders Center
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
    • Washington
      • Seattle, Washington, United States
        • University of Washington and VA Puget Sound
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin-Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

HD Community

Description

Inclusion:

  • 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.

Exclusion:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Study Group

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Ira Shoulson, M.D., University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 1999

Primary Completion (Actual)

December 17, 2009

Study Completion (Actual)

December 17, 2009

Study Registration Dates

First Submitted

January 23, 2003

First Submitted That Met QC Criteria

January 23, 2003

First Posted (Estimated)

January 24, 2003

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HG002449 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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