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

Recruiting now

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID

NCT02855476

Run by

University College, London

People needed

2500

Starts

2017-01-01

Last updated by the study team

2026-04-27

Who can join

Age: 11 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University Hospitals Plymouth NHS Trust — Plymouth, United Kingdom (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• John Hopkins University — Baltimore, Maryland, United States (enrolling)
• Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (enrolling)
• Cardiff University — Cardiff, United Kingdom (enrolling)
• Leeds Teaching Hospital Trust — Leeds, United Kingdom (enrolling)
• The Walton Centre NHS Foundation Trust — Liverpool, United Kingdom (enrolling)
• University College London Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
• St George's University Of London — London, United Kingdom (enrolling)
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (enrolling)
• Cenexel — Englewood, Colorado, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Texas Health Science Center — Houston, Texas, United States (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• North York General Hospital — Toronto, Ontario, Canada (enrolling)
• Centre Hospitalier Universitaire d'Angers — Angers, France (enrolling)
• Le Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (enrolling)
• University Hospital Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Dresden University — Dresden, Saxony, Germany (enrolling)
• St Josef And Elisabeth Hospital — Bochum, Germany (enrolling)
• University Hospital of Erlangen — Erlangen, Germany (enrolling)
• George Huntington Institute — Münster, Germany (enrolling)
• Kbo-Isar-Amper-Klinikum Taufkirchen (Vils) — Taufkirchen, Germany (enrolling)
• Lega Italiana Ricera Huntington — Rome, Italy (enrolling)
• The University of Auckland — Grafton, Auckland, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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