Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 18 for:    PHAROS
Previous Study | Return to List | Next Study

Prospective Huntington At Risk Observational Study (PHAROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00052143
Recruitment Status : Unknown
Verified February 2008 by Huntington Study Group.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2003
Last Update Posted : April 16, 2009
Sponsor:
Collaborators:
National Human Genome Research Institute (NHGRI)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Huntington Study Group

Tracking Information
First Submitted Date January 23, 2003
First Posted Date January 24, 2003
Last Update Posted Date April 16, 2009
Study Start Date July 1999
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Huntington At Risk Observational Study
Official Title Prospective Huntington At Risk Observational Study (PHAROS)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample
Sampling Method Non-Probability Sample
Study Population HD Community
Condition Huntington Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: June¬†23,¬†2005)
1001
Original Enrollment Same as current
Estimated Study Completion Date July 2010
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 26 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00052143
Other Study ID Numbers R01HG002449( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ira Shoulson, MD, Professor of Neurology, University of Rochester
Study Sponsor Huntington Study Group
Collaborators
  • National Human Genome Research Institute (NHGRI)
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Ira Shoulson, M.D. University of Rochester
PRS Account Huntington Study Group
Verification Date February 2008