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Huntington's DiseaseHDClarityNCT02855476

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

An observational study of Huntington's Disease, run by University College, London at 40 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 11 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Huntington's Disease
Type of treatment
Injection or infusion
How many people
2,500 participants
Where
40 sitesin 10 countries
Study dates
1 Jan 2017to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Participants across 8 clinical cohorts will be enrolled at multiple sites up to an estimated minimum of 2500 participants or until the study is terminated by either the Funding Source or Sponsor

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

40 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Katarzyna Schubert, PhD contact

hdclarity-cc@enroll-hd.org

Gail Owen, PhD contact

+44 1273 640 688

g.owen@ucl.ac.uk

40 sites in 10 countries

United Kingdom13 sites, 11 recruiting

  • Birmingham Huntingtons Disease Clinic

    Birmingham, West Midlands, B15 2 FG

    Elsa Benn, 0121 301 2363, e.benn@nhs.net

    Hugh Rickards, MB, ChB, MSc, FRCPsych, MD

    Recruiting

  • North Bristol NHS Trust

    Bristol, BS10 5NB

    Active, not recruiting

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0PY

    Katie Andresen, 01223 331141, kera2@cam.ac.uk

    Roger Barker

    Recruiting

  • Cardiff University

    Cardiff, CF24 4HQ

    Alison Johnson, 02920746394, alison.johnson@wales.nhs.uk

    Anne Rosser, MD

    Recruiting

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, Devon, EX2 5DW

    Julie Moss, 01392408181, julie.moss10@nhs.net

    Tim Harrower, MBBS

    Recruiting

  • Glasgow Clinical Research Facility

    Glasgow, Scotland, G51 4TF

    Helen Bannister, 0141 232 7600, helen.bannister@ggc.scot.nhs.uk

    James Herron, Dr

    Recruiting

  • Fife Health Board - Whyteman's Brae Hospital

    Kirkcaldy, KY1 2ND

    Active, not recruiting

  • Leeds Teaching Hospital Trust

    Leeds, LS7 4SA

    Dominique Barker, 0113 39 24679, dominique.barker@nhs.net

    Jeremy Cosgrove, MBBS

    Recruiting

  • The Walton Centre NHS Foundation Trust

    Liverpool, L9 7LJ

    Jenni Burns, BSc MSc, jenni.burns3@nhs.net

    Rhys Davies, MA BM BCh PhD FRCP

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

    Opeyemi Kinyomi, 0203 108 2638, o.kinyomi@ucl.ac.uk

    Edward Wild, MD, PhD

    Recruiting

  • St George's University Of London

    London, SW17 0RE

    Hae-Ree Seo, 0208 725 5375, HaeRee.Seo@stgeorges.nhs.uk

    Nayana Lahiri

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Zara Skitt, 01865 234309, zara.skitt@ouh.nhs.uk

    Richard Armstrong, MA, PhD, BMBCh, MRCP

    Recruiting

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 5FP

    Elizabeth Cray, 01752 439636, elizabethcray@nhs.net

    Daniel Lashley, MBBS

    Recruiting

Other trials in United Kingdom

United States6 sites, 5 recruiting

  • John Hopkins University

    Baltimore, Maryland, 21287

    Susan Robinson, 410-955-1349, srobin95@jhmi.edu

    Jee Bang, MPH, MD

    Recruiting

  • Cenexel

    Englewood, Colorado

    Jessica Crall, 303-867-5473, j.crall@cenexel.com

    Melanie Patton, m.patton@cenexel.com

    Recruiting

  • University of Texas Health Science Center

    Houston, Texas, 77030

    Brittany Duncan, 713-486-3134, brittany.j.duncan@uth.tmc.edu

    Erin Furr-Stimming

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Carol Wallace, RN, 615-936-1007, carol.l.wallace@vumc.org

    Amy Brown, MD

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20057

    Erin Koppel, 202-687-1525, ek875@georgetown.edu

    Karen Anderson, MD

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27109

    Completed

Other trials in United States

Germany6 sites, 6 recruiting

  • St Josef And Elisabeth Hospital

    Bochum, 44791

    Barbara Kaminski, b.kaminski@klinikum-bochum.de

    Carsten Saft

    Recruiting

  • Dresden University

    Dresden, Saxony, 01307

    Stefan Bräuer, 351- 458 2524, Stefan.Braeuer@ukdd.de

    Bjoern Falkenburger, MD

    Recruiting

  • University Hospital of Erlangen

    Erlangen, 91054

    Susanne Seifert, 09131-85-44751, susanne.seifert@uk-erlangen.de

    Winkler Jurgen

    Recruiting

  • George Huntington Institute

    Münster, 48149

    Svenja Aufenberg, +49-251-788-788-0, svenja.aufenberg@ghi-muenster.de

    Ralf Reilmann

    Recruiting

  • Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)

    Taufkirchen, 84416

    Michael Bachmaier, 08084-934-417, Michael.Bachmaier@kbo.de

    Alzbeta Mühlbäck, MD, PhD

    Recruiting

  • University Hospital Ulm

    Ulm, Baden-Wurttemberg, 89081

    Olga Kuvarzina, +49 731-500-63080, Olga.Kuvarzina@uniklinik-ulm.de

    Jan Lewerenz, MD

    Recruiting

Other trials in Germany

Canada4 sites, 2 recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

    Jane Ding, jading@toh.ca

    Tiago Mestre, Dr

    Recruiting

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

    Rebecca Searles, Rebecca.Searles@nygh.on.ca

    Philippe Rizek, Dr

    Recruiting

  • Centre for Movement Disorders

    Toronto, Ontario, M3B 2S7

    Completed

  • University of British Columbia, The Centre for Huntingtons Disease

    Vancouver, British Columbia, V6T 2B5

    Active, not recruiting

Other trials in Canada

Spain3 sites, 2 recruiting

  • Hospital de Sant Pau

    Barcelona, 08041

    Sofia Bonavita, +34 932919000 ext. 8533, SBonavita@santpau.cat

    Jamie Kulisevsky, MD, PhD

    Recruiting

  • Cruces University Hospital

    Bilbao, Biscay, 48903

    Active, not recruiting

  • Ramón y Cajal Universitary Hospital

    Madrid, 28034

    Rocio Lopez Perez, rocio.lopez.externo@salud.madrid.org

    Jose Louis Lopez Sendon, Dr

    Recruiting

Other trials in Spain

France2 sites, 2 recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49000

    Audrey Olivier, +33 241355615, auolivier@chu-angers.fr

    Christopher Verny, Dr

    Recruiting

  • Le Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33076

    Marie-Pierre Baudier, +33 (0)149 814 301, marie-pierre.baudier@chu-bordeaux.fr

    Cyril Goizet, Prof

    Recruiting

Other trials in France

Italy2 sites, 1 recruiting

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milan, 20133

    Active, not recruiting

  • Lega Italiana Ricera Huntington

    Rome, 00185

    Paola Mina, paola.mina@lirh.it

    Ferdinando Squitieri, MD

    Recruiting

Other trials in Italy

New Zealand2 sites, 2 recruiting

  • NZ Brain Research Institute

    Christchurch, Canterbury, 8011

    Laura Paermentier, Laura.Paermentier@cdhb.health.nz

    Tim Anderson, Prof

    Recruiting

  • The University of Auckland

    Grafton, Auckland, 1023

    Christina Buchanan, +64 9 307 4949, CBuchanan@adhb.govt.nz

    Richard Roxburgh, Prof

    Recruiting

Other trials in New Zealand

Poland1 site

  • Institute of Psychiatry and Neurology

    Warsaw, 02-957

    Active, not recruiting

Other trials in Poland

Portugal1 site, 1 recruiting

  • Gulbenkian Institute of Molecular Medicine

    Lisbon, 1649-028

    Ines Dias, +351925865042, neurociencias.movimento@gmail.com

    Leonor Correia-Guedes, MD

    Recruiting

Other trials in Portugal

About this study

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.

Read the detailed 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.

Medical subject headings
Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02855476
Study groupRoleWhat they receive
Early Pre-manifest HDParticipants 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 HDParticipants 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 HDParticipants 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 HDParticipants 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 HDParticipants 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 HDParticipants 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 HDParticipants 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 ControlParticipants 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: years N/A

Secondary outcomes (1)

  1. 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.

    Measured: years N/A

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855476
Sponsor's protocol ID
15/0519
Acronym
HDClarity
Status last verified
Apr 2026
First submitted
26 Jul 2016
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Huntington's Disease, run by University College, London at 40 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United Kingdom, United States, Germany, Canada, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katarzyna Schubert, PhD (hdclarity-cc@enroll-hd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is: (time frame: years N/A). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02855476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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