Collecting cerebrospinal fluid to aid in developing treatments for Huntington's disease
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
This study is collecting spinal fluid and blood samples from people with Huntington's disease to help find better treatments for the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 11 Years to 75 Years |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 40 sites (Englewood, Colorado and 39 other locations) |
| Trial ID | NCT02855476 on ClinicalTrials.gov |
What this trial studies
HDClarity is an observational initiative aimed at recruiting at least 2500 participants at various stages of Huntington's disease. The study focuses on collecting high-quality cerebrospinal fluid (CSF) and plasma samples to evaluate biomarkers and pathways relevant to the disease. Participants will attend annual visits for medical history assessments and biosample collection, with the option for additional sampling in the first year. This longitudinal approach allows for comprehensive data collection to facilitate therapeutic development for Huntington's disease.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-75 with various stages of Huntington's disease or healthy controls who have undergone genetic testing.
Not a fit: Patients with significant comorbidities or those currently participating in drug trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to the identification of new biomarkers and therapeutic targets for Huntington's disease.
How similar studies have performed: Other studies focusing on biomarker collection for neurodegenerative diseases have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Englewood, Colorado and 39 other locations
- Cenexel — Englewood, Colorado, United States (Recruiting)
- Georgetown University — Washington D.C., District of Columbia, United States (Recruiting)
- John Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Completed)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Texas Health Science Center — Houston, Texas, United States (Recruiting)
- University of British Columbia, The Centre for Huntingtons Disease — Vancouver, British Columbia, Canada (Active_not_recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- North York General Hospital — Toronto, Ontario, Canada (Recruiting)
- Centre for Movement Disorders — Toronto, Ontario, Canada (Completed)
- Centre Hospitalier Universitaire d'Angers — Angers, France (Recruiting)
- Le Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (Recruiting)
- University Hospital Ulm — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- Dresden University — Dresden, Saxony, Germany (Recruiting)
- St Josef And Elisabeth Hospital — Bochum, Germany (Recruiting)
- University Hospital of Erlangen — Erlangen, Germany (Recruiting)
- George Huntington Institute — Münster, Germany (Recruiting)
- Kbo-Isar-Amper-Klinikum Taufkirchen (Vils) — Taufkirchen, Germany (Recruiting)
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta — Milan, Italy (Active_not_recruiting)
- Lega Italiana Ricera Huntington — Rome, Italy (Recruiting)
- The University of Auckland — Grafton, Auckland, New Zealand (Recruiting)
- NZ Brain Research Institute — Christchurch, Canterbury, New Zealand (Recruiting)
- Institute of Psychiatry and Neurology — Warsaw, Poland (Active_not_recruiting)
- Gulbenkian Institute of Molecular Medicine — Lisbon, Portugal (Recruiting)
- Cruces University Hospital — Bilbao, Biscay, Spain (Active_not_recruiting)
- Hospital de Sant Pau — Barcelona, Spain (Recruiting)
- Ramón y Cajal Universitary Hospital — Madrid, Spain (Recruiting)
- Royal Devon & Exeter NHS Foundation Trust — Exeter, Devon, United Kingdom (Recruiting)
- Glasgow Clinical Research Facility — Glasgow, Scotland, United Kingdom (Recruiting)
- Birmingham Huntingtons Disease Clinic — Birmingham, West Midlands, United Kingdom (Recruiting)
- North Bristol NHS Trust — Bristol, United Kingdom (Active_not_recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Cardiff University — Cardiff, United Kingdom (Recruiting)
- Fife Health Board - Whyteman's Brae Hospital — Kirkcaldy, United Kingdom (Active_not_recruiting)
- Leeds Teaching Hospital Trust — Leeds, United Kingdom (Recruiting)
- The Walton Centre NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- St George's University Of London — London, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- University Hospitals Plymouth NHS Trust — Plymouth, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Edward J Wild, MA, MB BChir, MRCP, PhD — University College, London
- Study coordinator: Katarzyna Schubert, PhD
- Email: hdclarity-cc@enroll-hd.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.