Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Secondary ID [1] 0 0
Enroll -HD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Level
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
Functional Assessments: UHDRS '99 Total Functional Capacity, UHDRS '99 Functional Assessment Scale, UHDRS '99 Independence Scale
Timepoint [2] 0 0
through study completion, an average of 1 year
Primary outcome [3] 0 0
Problem Behaviors Assessment-Short (PBA-s)
Timepoint [3] 0 0
through study completion, an average of 1 year
Primary outcome [4] 0 0
Cognitive Assessments: Symbol Digit Modality Test; Stroop Color Naming; Stroop Word Reading; Categorical Verbal Fluency
Timepoint [4] 0 0
through study completion, an average of 1 year

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2062
Actual
Sample size
Target
35000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Monash University - Melbourne
Recruitment hospital [3] 0 0
The Neurosciences Unit - North Metropolitan Hospital - Perth
Recruitment hospital [4] 0 0
University of Melbourne, Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3800 - Melbourne
Recruitment postcode(s) [3] 0 0
6010 - Perth
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Vermont
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Argentina
State/province [36] 0 0
Buenos Aires
Country [37] 0 0
Austria
State/province [37] 0 0
Innsbruck
Country [38] 0 0
Belgium
State/province [38] 0 0
Vlaams-Brabant
Country [39] 0 0
Belgium
State/province [39] 0 0
Bruxelles
Country [40] 0 0
Belgium
State/province [40] 0 0
Charleroi
Country [41] 0 0
Belgium
State/province [41] 0 0
Saint-Servais
Country [42] 0 0
Canada
State/province [42] 0 0
Alberta
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
Nova Scotia
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Chile
State/province [47] 0 0
Santiago
Country [48] 0 0
Colombia
State/province [48] 0 0
Antioquia
Country [49] 0 0
Colombia
State/province [49] 0 0
Cundinamarca
Country [50] 0 0
Denmark
State/province [50] 0 0
Aarhus
Country [51] 0 0
Denmark
State/province [51] 0 0
Copenhagen
Country [52] 0 0
Denmark
State/province [52] 0 0
Odense
Country [53] 0 0
France
State/province [53] 0 0
Alsace Lorraine
Country [54] 0 0
France
State/province [54] 0 0
Amiens
Country [55] 0 0
France
State/province [55] 0 0
Angers
Country [56] 0 0
France
State/province [56] 0 0
Bordeaux
Country [57] 0 0
France
State/province [57] 0 0
Clermont-Ferrand
Country [58] 0 0
France
State/province [58] 0 0
Créteil
Country [59] 0 0
France
State/province [59] 0 0
LILLE Cedex
Country [60] 0 0
France
State/province [60] 0 0
Marseille
Country [61] 0 0
France
State/province [61] 0 0
Montpellier
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Toulouse
Country [64] 0 0
Germany
State/province [64] 0 0
Aachen
Country [65] 0 0
Germany
State/province [65] 0 0
Berlin
Country [66] 0 0
Germany
State/province [66] 0 0
Bochum
Country [67] 0 0
Germany
State/province [67] 0 0
Dresden
Country [68] 0 0
Germany
State/province [68] 0 0
Erlangen
Country [69] 0 0
Germany
State/province [69] 0 0
Freiburg
Country [70] 0 0
Germany
State/province [70] 0 0
Kassel
Country [71] 0 0
Germany
State/province [71] 0 0
Lübeck
Country [72] 0 0
Germany
State/province [72] 0 0
Marburg
Country [73] 0 0
Germany
State/province [73] 0 0
Munich
Country [74] 0 0
Germany
State/province [74] 0 0
Münster
Country [75] 0 0
Germany
State/province [75] 0 0
Taufkirchen
Country [76] 0 0
Germany
State/province [76] 0 0
Ulm
Country [77] 0 0
Germany
State/province [77] 0 0
Würzburg
Country [78] 0 0
Ireland
State/province [78] 0 0
Republic Of Ireland
Country [79] 0 0
Italy
State/province [79] 0 0
MI
Country [80] 0 0
Italy
State/province [80] 0 0
Bari
Country [81] 0 0
Italy
State/province [81] 0 0
Bologna
Country [82] 0 0
Italy
State/province [82] 0 0
Genoa
Country [83] 0 0
Italy
State/province [83] 0 0
Milan
Country [84] 0 0
Italy
State/province [84] 0 0
Napoli
Country [85] 0 0
Italy
State/province [85] 0 0
Rome
Country [86] 0 0
Netherlands
State/province [86] 0 0
Groningen
Country [87] 0 0
Netherlands
State/province [87] 0 0
Leiden
Country [88] 0 0
Netherlands
State/province [88] 0 0
Maastricht
Country [89] 0 0
New Zealand
State/province [89] 0 0
Auckland
Country [90] 0 0
New Zealand
State/province [90] 0 0
Christchurch
Country [91] 0 0
New Zealand
State/province [91] 0 0
Wellington
Country [92] 0 0
Poland
State/province [92] 0 0
Gdansk
Country [93] 0 0
Poland
State/province [93] 0 0
Katowice
Country [94] 0 0
Poland
State/province [94] 0 0
Kraków
Country [95] 0 0
Poland
State/province [95] 0 0
Poznan
Country [96] 0 0
Poland
State/province [96] 0 0
Warsaw
Country [97] 0 0
Portugal
State/province [97] 0 0
Amadora
Country [98] 0 0
Portugal
State/province [98] 0 0
Coimbra
Country [99] 0 0
Portugal
State/province [99] 0 0
Lisbon
Country [100] 0 0
Portugal
State/province [100] 0 0
Porto
Country [101] 0 0
Spain
State/province [101] 0 0
Badajoz
Country [102] 0 0
Spain
State/province [102] 0 0
Barakaldo
Country [103] 0 0
Spain
State/province [103] 0 0
Barcelona,
Country [104] 0 0
Spain
State/province [104] 0 0
Barcelona
Country [105] 0 0
Spain
State/province [105] 0 0
Burgos
Country [106] 0 0
Spain
State/province [106] 0 0
Madrid
Country [107] 0 0
Spain
State/province [107] 0 0
Palma De Mallorca
Country [108] 0 0
Spain
State/province [108] 0 0
Pamplona
Country [109] 0 0
Spain
State/province [109] 0 0
Valencia
Country [110] 0 0
Switzerland
State/province [110] 0 0
Gümligen
Country [111] 0 0
Switzerland
State/province [111] 0 0
Zürich
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Devon
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Leicestershire
Country [114] 0 0
United Kingdom
State/province [114] 0 0
UK
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Aberdeen
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Birmingham
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Cambridge
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Cardiff
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Dundee
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Edinburgh
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Glasgow
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Kilmarnock
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Larbert
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Leeds
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Liverpool
Country [126] 0 0
United Kingdom
State/province [126] 0 0
London
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Manchester
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Newcastle-upon-Tyne
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Northampton
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Oxford
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Plymouth
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Poole
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Reading
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Sheffield
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Southampton
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Stoke-on-Trent
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Swindon

Funding & Sponsors
Primary sponsor type
Other
Name
CHDI Foundation, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01574053
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bernhard G Landwehrmeyer, MD, PhD
Address 0 0
University of Ulm
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Noopur Modi
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01574053