HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Huntington's Disease Clinical Trial

— HDClarity  

Official title:

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855476
• Other study ID #: 15/0519
• Status: Recruiting
• Start date: January 2017
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: Katarzyna Schubert, PhD
• Email: hdclarity-cc[@]enroll-hd.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.

Description:

This is a longitudinal open-ended observational study. Participants will attend two annual study visits, an Annual Screening Visit followed by an Annual Sampling Visit, and may also attend an optional visit during the first year of enrollment, an Optional Repeat Sampling Visit.

During the Annual Screening Visit, medical history, and clinical and phenotypic data will be obtained. Participants who meet the eligibility requirements of the study and are willing to continue in the study, will return for an Annual Sampling Visit. During that visit, biosamples will be collected following a fast of at least 6 hours, or overnight: blood will be obtained via venipuncture and CSF will be obtained via lumbar puncture. Some participants may be invited to return for an Optional Repeat Sampling Visit approximately 4-8 weeks after the Annual Sampling Visit during their first year of enrolment.

The annual visits are at regular intervals after the first Annual Screening Visit (i.e. at 1, 2, 3 years and so on) ± 2 months. Participants will be encouraged to complete all annual visits; however, they are under no obligation to take part and will be able to skip annual visit without being discontinued from the study. Participants who do not come for an Annual Sampling Visit for three consecutive years will be discontinued from the study, but they may enrol again at a later date, if they so consent. Participants who have already completed HDClarity Sampling Visits under earlier versions of this protocol may also participate in the longitudinal study if they meet the eligibility criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Centre for Movement Disorders	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	University of British Columbia, The Centre for Huntingtons Disease	Vancouver	British Columbia
France	Centre Hospitalier Universitaire d'Angers	Angers
Germany	St Josef And Elisabeth Hospital	Bochum
Germany	Dresden University	Dresden	Saxony
Germany	University Hospital of Erlangen	Erlangen
Germany	George Huntington Institute	Münster
Germany	Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)	Taufkirchen
Germany	University Hospital Ulm	Ulm	Baden-Württemberg
Italy	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Milan
Italy	Lega Italiana Ricera Huntington	Rome
New Zealand	NZ Brain Research Institute	Christchurch	Canterbury
New Zealand	The University of Auckland	Grafton	Auckland
Poland	Institute of Psychiatry and Neurology	Warsaw
Spain	Hospital de Sant Pau	Barcelona
Spain	Cruces University Hospital	Bilbao	Biscay
United Kingdom	Birmingham Huntingtons Disease Clinic	Birmingham	West Midlands
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff University	Cardiff
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter	Devon
United Kingdom	Glasgow Clinical Research Facility	Glasgow	Scotland
United Kingdom	Fife Health Board - Whyteman's Brae Hospital	Kirkcaldy
United Kingdom	Leeds Teaching Hospital Trust	Leeds
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool
United Kingdom	St George's University Of London	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United States	John Hopkins University	Baltimore	Maryland
United States	Cenexel	Englewood	Colorado
United States	University of Texas Health Science Center	Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Georgetown University	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	CHDI Foundation, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  New Zealand,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is:	To generate a high quality CSF sample collection for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD.	years N/A
Secondary	The secondary objectives of this study are:	To generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.; To collect phenotypic and clinical data for each participant.	years N/A

External Links

•   Study website