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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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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
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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/ct2/show/NCT01574053
Trial related presentations / publications
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
Info@Enroll-HD.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01574053