Recruiting

Observational Study

Sponsor:

University College, London

Code:

NCT02855476

Conditions

Huntington's Disease

Eligibility Criteria

Sex: All

Age: 11 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Huntington's Disease

Study ID

NCT02855476

Start date

Jan 1, 2017

Status verified date

Apr, 2026

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

Early Pre-manifest HD

Participants 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 HD

Participants 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 HD

Participants 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 HD

Participants 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 HD

Participants 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 HD

Participants 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 HD

Participants 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 Control

Participants 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).

Primary outcome measure

  • The primary objective of this study is: [ Time Frame: years N/A ]

Central Contacts and Locations

Central contacts

Katarzyna Schubert, PhD

hdclarity-cc@enroll-hd.org

Gail Owen, PhD

+44 1273 640 688g.owen@ucl.ac.uk

Locations

Cenexel

Recruiting

Englewood, Colorado, United States

Contacts

Jessica Crall

303-867-5473j.crall@cenexel.com

Melanie Patton

m.patton@cenexel.com

Principal Investigator:

Meagen Salinas, MD

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20057

Contacts

Erin Koppel

202-687-1525ek875@georgetown.edu

Principal Investigator:

Karen Anderson, MD

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Susan Robinson

410-955-1349srobin95@jhmi.edu

Principal Investigator:

Jee Bang, MPH, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Carol Wallace, RN

615-936-1007carol.l.wallace@vumc.org

Principal Investigator:

Amy Brown, MD

University of Texas Health Science Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Brittany Duncan

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

Principal Investigator:

Erin Furr-Stimming

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Jane Ding

jading@toh.ca

Principal Investigator:

Tiago Mestre, Dr

North York General Hospital

Recruiting

Toronto, Ontario, Canada, M2K 1E1

Contacts

Rebecca Searles

Rebecca.Searles@nygh.on.ca

Principal Investigator:

Philippe Rizek, Dr

More Information

Sponsor

University College, London

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University College, London on 2026-04-27.