Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2017-02-28
2017-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Pre-Manifest HDGEC Participant
FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
Early-Manifest HDGEC Participant
FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
Corresponding HDGEC participant Companion
FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
Interventions
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FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years of age
3. Must be fluent in English and had his primary education in English
4. Must be willing and able to provide written informed consent
Pre-Manifest HDGECs
Criteria 1-4, and:
1. CAG length greater than or equal to 40
2. Disease Burden Score greater than or equal to 250 (calculated by the equation:
\[CAGn-35.5\] X age)
3. UHDRS Diagnostic Confidence Level (DCL) \< 3
4. At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.
Early-Manifest (Stage 1\&2) HDGECs
Criteria 1-4, and:
1. CAG length greater than or equal to 36
2. DCL=4
3. UHDRS Total Functional Capacity (TFC) ≥7
4. Participants whose companion is willing to participate in this study and complete the scale independently
Main criteria for exclusion:
1. Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee
2. Currently participating in a clinical trial involving an investigational medicinal product
18 Years
ALL
No
Sponsors
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Dr. Glenn T. Stebbins (Rush University Medical Center )
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Nancy LaPelle
UNKNOWN
CHDI Foundation, Inc.
OTHER
Responsible Party
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Locations
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Rocky Mountain Movement Disorders Center, P.C.
Englewood, Colorado, United States
Hereditary Neurology Disease Centre, Inc.
Wichita, Kansas, United States
Columbia University
New York, New York, United States
CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting)
Toronto, Ontario, Canada
Countries
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Other Identifiers
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C-000316
Identifier Type: -
Identifier Source: org_study_id
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