At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Not specified by the sponsor
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
HDClarity is a study collecting cerebrospinal fluid (the fluid around the brain and spine) from people with Huntington's disease and from volunteers without it. The samples will help researchers develop new treatments. The study is run by University College, London.
Who can take part
- Age 18-75 for people without Huntington's disease, and for those with early or late premanifest Huntington's disease or incomplete penetrance Huntington's disease
- Age 21-75 for people with early, moderate or advanced manifest Huntington's disease
- Age 11 or over for juvenile Huntington's disease
- You are enrolled as a Huntington's disease participant
- You can consent yourself, or a legal representative (a parent or guardian for young people) can consent for you
- You can follow the study procedures
- Most participants (except family and community controls) must have had a genetic test for Huntington's disease
Who may not be able to
- You took part in a drug trial within 30 days of any sampling visit
- Your medication changed within 30 days (for example antidepressants, psychoactive or psychotropic medicines, or other medicines or supplements used to treat Huntington's disease)
- You took antiplatelet or anticoagulant (blood-thinning) medicines within 14 days
- You have a significant other health condition
- You have needle phobia, headaches, spinal surgery or a spinal deformity
- You have a clotting or bruising disorder
- Your screening blood tests are more than 10% outside the normal range
- You use drugs or alcohol in a way the study considers abuse
- You are female, able to have children, and have a positive pregnancy test at any screening or sampling visit
- You are unlikely to follow the study rules or do not want to take part
- You had a serious bad reaction to this study's procedures or any lumbar puncture in the previous 30 days
What taking part involves
- • Providing cerebrospinal fluid samples, collected by a lumbar puncture (a needle in the lower back)
- • Screening blood and urine tests
- • Not stated — ask the trial team
Time commitment: Taking part involves screening and sampling visits with lumbar punctures; the total number of visits and study duration are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 11 Years to 75 Years
- Who
- All
- Number of participants
- 2,500
- Started
- 2017-01-01
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for huntington's disease
- • Clinical study - 2,500 participants
- • HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD)
Who can take part?
- • Ages 11 Years to 75 Years
- • Diagnosed with huntington's disease
Where?
- • Exeter - Royal Devon & Exeter NHS Foundation Trust
- • Glasgow - Glasgow Clinical Research Facility
- • Birmingham - Birmingham Huntingtons Disease Clinic
- • Bristol - North Bristol NHS Trust
- • +9 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 11 Years - 75 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ had a genetic test for HD
What the study is looking for
- ✓Age (18-75 years controls, early/late premanifest HD and incomplete penetrance HD, 21-75 years...
- ✓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
Who cannot take part
- ✗Drug trial within 30 days of any sampling visit
- ✗Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to...
- ✗Antiplatelet or anticoagulant therapy within 14 days
- ✗Significant other health condition
- ✗Needle phobia, headache, spinal surgery / deformity
See the full criteria
Where Is This Study? (13 UK sites)
Royal Devon & Exeter NHS Foundation Trust
Exeter EX2 5DW, United Kingdom
Glasgow Clinical Research Facility
Glasgow G51 4TF, United Kingdom
Birmingham Huntingtons Disease Clinic
Birmingham B15 2 FG, United Kingdom
North Bristol NHS Trust
Bristol BS10 5NB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0PY, United Kingdom
Cardiff University
Cardiff CF24 4HQ, United Kingdom
Fife Health Board - Whyteman's Brae Hospital
Kirkcaldy KY1 2ND, United Kingdom
Leeds Teaching Hospital Trust
Leeds LS7 4SA, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool L9 7LJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
St George's University Of London
London SW17 0RE, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth PL6 5FP, United Kingdom
How to Get in Touch
Katarzyna Schubert, PhD
Sponsor contactCONTACT
Gail Owen, PhD
Sponsor contactCONTACT