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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02855476




Registration number
NCT02855476
Ethics application status
Date submitted
26/07/2016
Date registered
4/08/2016

Titles & IDs
Public title
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Scientific title
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Secondary ID [1] 0 0
15/0519
Universal Trial Number (UTN)
Trial acronym
HDClarity
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
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Early Pre-manifest HD - Participants eligible are persons who meet the following criteria:

1. Are 18-75 years of age, inclusive, at the time of consent; and
2. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score \< 4; and
3. Have CAG expansion = 40; and
4. Have burden of pathology score, computed as (CAG - 35.5) × age, \< 250

Late Pre-manifest HD - Participants eligible are persons who meet the following criteria:

1. Are 18-75 years of age, inclusive, at the time of consent; and
2. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score \< 4; and
3. Have CAG expansion = 40; and
4. Have burden of pathology score, computed as (CAG - 35.5) x age, = 250

Early Manifest HD - Participants eligible are persons who meet the following criteria:

1. Are 21-75 years of age, inclusive, at the time of consent; and
2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
3. Have CAG expansion = 40; and
4. Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive

Moderate Manifest HD - Participants eligible are persons who meet the following criteria:

1. Are 21-75 years of age, inclusive, at the time of consent; and
2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
3. Have CAG expansion = 40; and
4. Have Stage III HD, defined as UHDRS TFC scores between 3 and 6, inclusive

Advanced Manifest HD - Participants eligible are persons who meet the following criteria:

1. Are 21-75 years of age, inclusive, at the time of consent; and
2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
3. Have CAG expansion = 40; and
4. Have Stage IV HD, defined as UHDRS TFC scores between 0 and 2, inclusive

Incomplete Penetrance HD - Participants eligible are persons who meet the following criteria:

1. Are 18-75 years of age, inclusive, at the time of consent; and
2. Have CAG expansion of 36-39

Juvenile Manifest HD - Participants eligible are persons who meet the following criteria:

1. Are =11 years of age at the time of consent; and
2. Have clinical diagnostic features of juvenile HD, defined as UHDRS Diagnostic Confidence Score = 4 aged =20 years; and
3. Have CAG expansion = 40

Healthy Control - Participants eligible are persons who meet the following criteria:

1. Are 18-75 years of age, inclusive, at the time of consent; and
2. Have no known family history of HD; or
3. Have known family history of HD but have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG \< 36).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is:
Timepoint [1] 0 0
years N/A
Secondary outcome [1] 0 0
The secondary objectives of this study are:
Timepoint [1] 0 0
years N/A

Eligibility
Key inclusion criteria
* Age (18-75 years controls, early/late premanifest HD and incomplete penetrance HD, 21-75 years early/moderate/advanced manifest HD, =11 years juvenile HD)
* Enroll HD participant
* Capable of consenting or have a legal representative (parent/guardian for juveniles)
* Capable of complying with study procedures
* All participants other than family and community controls must have had a genetic test for HD
Minimum age
11 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Drug trial within 30 days of any sampling visit
* Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)
* Antiplatelet or anticoagulant therapy within 14 days
* Significant comorbidity
* Needle phobia, headache, spinal surgery / deformity
* Clotting or bruising disorder
* Screening blood test abnormalities >10% outside normal range
* Drug / alcohol abuse
* Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential
* Predictable non compliance or unwillingness
* Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days

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
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
France
State/province [9] 0 0
Angers
Country [10] 0 0
Germany
State/province [10] 0 0
Baden-Württemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Saxony
Country [12] 0 0
Germany
State/province [12] 0 0
Bochum
Country [13] 0 0
Germany
State/province [13] 0 0
Erlangen
Country [14] 0 0
Germany
State/province [14] 0 0
Münster
Country [15] 0 0
Germany
State/province [15] 0 0
Taufkirchen
Country [16] 0 0
Italy
State/province [16] 0 0
Milan
Country [17] 0 0
Italy
State/province [17] 0 0
Rome
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland
Country [19] 0 0
New Zealand
State/province [19] 0 0
Canterbury
Country [20] 0 0
Poland
State/province [20] 0 0
Warsaw
Country [21] 0 0
Spain
State/province [21] 0 0
Biscay
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Devon
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Scotland
Country [25] 0 0
United Kingdom
State/province [25] 0 0
West Midlands
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Bristol
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridge
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Cardiff
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Kirkcaldy
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Leeds
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Liverpool
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Oxford
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CHDI Foundation, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward J Wild, MA, MB BChir, MRCP, PhD
Address 0 0
University College, London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katarzyna Schubert, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The cerebrospinal fluid (CSF) and plasma samples collected in this study will be the basis of future biomarker analysis studies. A Scientific Advisory Committee which will decide how the samples will be analysed.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02855476