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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01574053
Registration number
NCT01574053
Ethics application status
Date submitted
6/04/2012
Date registered
10/04/2012
Date last updated
28/02/2024
Titles & IDs
Public title
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
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Scientific title
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
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Secondary ID [1]
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Enroll -HD
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Level
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Assessment method [1]
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The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. UHDRS 99 Motor, UHDRS Diagnostic Confidence Level.
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Timepoint [1]
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through study completion, an average of 1 year
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Primary outcome [2]
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Functional Assessments: UHDRS '99 Total Functional Capacity, UHDRS '99 Functional Assessment Scale, UHDRS '99 Independence Scale
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Assessment method [2]
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The Total Functional Capacity, Functional Assessment and Independence Subscales of the UHDRS '99 will be used to assess participants' functional status. The Total Functional Capacity scale has established psychometric properties including inter-rater reliability and validity, based on radiographic measures of disease progression.
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Timepoint [2]
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Primary outcome [3]
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Problem Behaviors Assessment-Short (PBA-s)
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Assessment method [3]
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The Problem Behavioral Assessment Short Version (PBA-s) will be used to perform behavioral assessments. This instrument measures frequency and severity of symptoms related to altered affect, thought content and coping styles.
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Timepoint [3]
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Primary outcome [4]
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Cognitive Assessments: Symbol Digit Modality Test; Stroop Color Naming; Stroop Word Reading; Categorical Verbal Fluency
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Assessment method [4]
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Cognition will be assessed using the Categorical Verbal Fluency Test, Symbol Digit Modality Test and Stroop Color and Word Reading Test. Verbal fluency is a commonly used neuropsychological test which examines the ability to spontaneously produce words orally within a fixed time span. For category fluency, words must be produced according to semantic constraints. The measure of performance used will be the number of correctly generated words within 60 seconds.
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Timepoint [4]
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through study completion, an average of 1 year
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Eligibility
Key inclusion criteria
* Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
* Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.
These two major categories can be further subdivided into six different subgroups of eligible individuals:
* Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
* Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
* Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
* Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
* Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
* Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.
Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Individuals who do not meet inclusion criteria,
* Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
* For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).
Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2062
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Actual
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Sample size
Target
35000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Monash University - Melbourne
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The Neurosciences Unit - North Metropolitan Hospital - Perth
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University of Melbourne, Royal Melbourne Hospital - Parkville
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2145 - Westmead
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3800 - Melbourne
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6010 - Perth
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3052 - Parkville
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Stoke-on-Trent
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United Kingdom
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Swindon
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Funding & Sponsors
Primary sponsor type
Other
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CHDI Foundation, Inc.
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Ethics approval
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Summary
Brief summary
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
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Trial website
https://clinicaltrials.gov/study/NCT01574053
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Trial related presentations / publications
Landwehrmeyer GB, Fitzer-Attas CJ, Giuliano JD, Goncalves N, Anderson KE, Cardoso F, Ferreira JJ, Mestre TA, Stout JC, Sampaio C. Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease. Mov Disord Clin Pract. 2016 Jun 22;4(2):212-224. doi: 10.1002/mdc3.12388. eCollection 2017 Mar-Apr.
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Public notes
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Contacts
Principal investigator
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Bernhard G Landwehrmeyer, MD, PhD
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University of Ulm
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Contact person for public queries
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Noopur Modi
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01574053
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