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| Sponsor: | Huntington Study Group |
|---|---|
| Collaborators: |
National Human Genome Research Institute (NHGRI) National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Huntington Study Group |
| ClinicalTrials.gov Identifier: | NCT00052143 |
Purpose
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.
| Condition |
|---|
|
Huntington Disease |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Prospective Huntington At Risk Observational Study (PHAROS) |
Blood sample
| Enrollment: | 1001 |
| Study Start Date: | July 1999 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 26 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
HD Community
Inclusion:
Exclusion:
Individuals Who:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Mayo Clinic Arizona | |
| Phoenix, Arizona, United States | |
| United States, California | |
| University of California at San Diego | |
| LaJolla, California, United States | |
| UCLA School of Medicine | |
| Los Angeles, California, United States | |
| University of California, Davis | |
| Sacramento, California, United States | |
| United States, Colorado | |
| Colorado Neurological Institute | |
| Englewood, Colorado, United States | |
| United States, Connecticut | |
| University of Connecticut | |
| Hartford, Connecticut, United States | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States | |
| United States, Florida | |
| University of Miami School of Medicine | |
| Miami, Florida, United States | |
| University of South Florida | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States | |
| Hereditary Neurological Disease Center | |
| Wichita, Kansas, United States | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States | |
| University of Maryland at Baltimore | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| UMDNJ Huntington Disease Service Center | |
| Stratford, New Jersey, United States | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States | |
| North Shore-LIJ Health System | |
| Manhasset, New York, United States | |
| Columbia University | |
| New York, New York, United States | |
| University of Rochester | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, Rhode Island | |
| NeuroHealth Parkinson's Disease Movement Disorders Center | |
| Pawtucket, Rhode Island, United States | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States | |
| United States, Washington | |
| University of Washington and VA Puget Sound | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| Medical College of Wisconsin-Milwaukee | |
| Milwaukee, Wisconsin, United States | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada | |
| University of Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| The Centre for Addiction and Mental Health | |
| Markham, Ontario, Canada | |
| Canada, Quebec | |
| Hotel-Dieu Hospital-CHUM | |
| Montreal, Quebec, Canada | |
| Principal Investigator: | Ira Shoulson, M.D. | University of Rochester |
More Information
| Responsible Party: | University of Rochester ( Ira Shoulson, MD, Professor of Neurology ) |
| Study ID Numbers: | R01HG02449 |
| Study First Received: | January 23, 2003 |
| Last Updated: | April 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052143 History of Changes |
| Health Authority: | United States: Federal Government |
|
Huntington's disease HD Huntington disease |
|
Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Cognition Disorders Chorea |
Delirium, Dementia, Amnestic, Cognitive Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Mental Disorders Movement Disorders Dementia Huntington Disease |