Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052143
Status:
COMPLETED
Last Update Posted:
2009-04-16
First Post:
2003-01-23
Brief Title:
Prospective Huntington At Risk Observational Study
Sponsor:
Huntington Study Group
Organization:
Huntington Study Group
Study Overview
Official Title:
Prospective Huntington At Risk Observational Study PHAROS
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAROS
Brief Summary:
The purpose of this study is to define the natural history and experiences of people who are at risk for developing Huntingtons disease but who do not know their genetic status
Detailed Description:
Huntingtons 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 Huntingtons 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
Participants in the study will be evaluated every 9 months for 5 years using the Unified Huntingtons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None