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Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

Sponsor: CHDI Foundation, Inc.

NCT ID: NCT01574053

View on ClinicalTrials.gov ↗

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
Study runs about 594 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

Enroll-HD is an ongoing registry study following people affected by Huntington's disease around the world. It is run by the CHDI Foundation, Inc. It collects information from people who carry the Huntington's disease gene mutation and from people who do not, to help research.

Who can take part

  • People who carry the gene change (mutation) that causes Huntington's disease, whether or not they have symptoms
  • Carriers who have clear clinical signs of Huntington's disease (called 'manifest' or 'motor-manifest')
  • Carriers who do not yet have signs that a doctor regards as diagnostic of Huntington's disease (called 'pre-manifest')
  • Blood relatives of carriers who have not had a predictive test, so it is not known whether they carry the gene
  • Blood relatives who have had a predictive test showing they do not carry the gene change
  • Family members or others not related by blood, such as spouses, partners and caregivers (called 'family controls')
  • People with no link to Huntington's disease families, to provide comparison data (called 'community controls')
  • People under 18 may take part if they have juvenile-onset Huntington's disease

Who may not be able to

  • People who do not meet the inclusion criteria
  • People with chorea (jerky movements) who have tested negative for the Huntington's disease gene change
  • Community controls with a major central nervous system disorder, such as stroke, Parkinson's disease or multiple sclerosis

What taking part involves

  • • Not stated — ask the trial team
  • • Participants are classified into groups based on their gene test status and clinical signs; some gene testing is done as part of the study, and neither the researchers nor participants are told the result of that research reclassification

Time commitment: Not stated — ask the trial team about how often visits happen, how long the study lasts, and what taking part involves.

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
18 Years and over
Who
All
Number of participants
35,000
Started
2012-07
Last checked
2024-02

Plain English Summary

What is this study?

  • • Testing a new treatment for huntington's disease
  • • Clinical study - 35,000 participants
  • • Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with huntington's disease

Where?

  • • Exeter - Royal Devon and Exeter NHS Foundation Trust
  • • Narborough - Leicestershire Partnership
  • • Bristol - North Bristol NHS Trust
  • • Kirkcaldy - Fife Health Board
  • • +26 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

More detail

The primary objective of Enroll-HD is to develop a comprehensive repository of prospective and systematically collected clinical research data (demography, clinical features, family history, genetic characteristics) and biological specimens (blood) from individuals with manifest HD, unaffected individuals known to carry the HD mutation or at risk of carrying the HD mutation, and control research participants (e.g., spouses, siblings or offspring of HD mutation carriers known not to carry the HD mutation). Enroll-HD is conceived as a broad-based and long-term project to maximize the efficiencies of non-clinical research and participation in clinical research. With more than 150 active clinical sites in 23 countries, Enroll-HD is now the largest HD database available and is accessible to any interested researcher - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Huntington's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

Genotype Negativeof a negative

What the study is looking for

  • ✓Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene...
  • ✓Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD...
  • ✓These two major categories can be further subdivided into six different subgroups of eligible individuals:
  • ✓Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as...
  • ✓Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.

Who cannot take part

  • ✗Individuals who do not meet inclusion criteria,
  • ✗Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
  • ✗For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g....
  • ✗Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
See the full criteria
Inclusion Criteria: * Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation. * Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation. These two major categories can be further subdivided into six different subgroups of eligible individuals: * Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD. * Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD. * Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status. * Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation. * Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers). * Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies. Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification. Exclusion Criteria: * Individuals who do not meet inclusion criteria, * Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation. * For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.). Participants under 18 may be eligible to participate (if they have juvenile-onset HD).

Where Is This Study? (30 UK sites)

Royal Devon and Exeter NHS Foundation Trust

Exeter EX25DW, United Kingdom

Recruiting
Site contact (verified)
Timothy HarrowerPrincipal Investigator

Leicestershire Partnership

Narborough LE19 4SL, United Kingdom

Recruiting
Site contact (verified)
Reza KianaPrincipal Investigator

North Bristol NHS Trust

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Elizabeth CoulthardPrincipal Investigator

Fife Health Board

Kirkcaldy KY1 2ND, United Kingdom

Recruiting
Site contact (verified)
Simon RubidgePrincipal Investigator

Betsi Cadwaladr University Health Board

Wrexham LL13 7TD, United Kingdom

Recruiting
Site contact (verified)
Alberto SalmoiraghiPrincipal Investigator

University of Aberdeen

Aberdeen AB25 2ZA, United Kingdom

Recruiting
Site contact (verified)
Zosia MiedzybrodzkaPrincipal Investigator

Birmingham and Solihull Mental Health NHS Foundation Trust

Birmingham B15 2FG, United Kingdom

Recruiting
Site contact (verified)
Hugh RickardsPrincipal Investigator

University of Cambridge

Cambridge CB2 0PY, United Kingdom

Recruiting
Site contact (verified)
Roger BarkerPrincipal Investigator

Cardiff University

Cardiff CF24 4HQ, United Kingdom

Recruiting
Site contact (verified)
Anne RosserPrincipal Investigator

Tayside Health Board

Dundee DD1 9SY, United Kingdom

Recruiting
Site contact (verified)
Jonathan BergPrincipal Investigator

Lothian Health Board

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Peter FoleyPrincipal Investigator

Greater Glasgow Health Board

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Stuart RitchiePrincipal Investigator

Ayrshire Central Hospital

Kilmarnock KA2 OBB, United Kingdom

TERMINATED

NHS Forth Valley

Larbert FK5 4WR, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Emma McDonough

fv.randd-depart@nhs.scot---

Leeds Teaching Hospitals

Leeds LS7 4SA, United Kingdom

Recruiting
Site contact (verified)
Alison KrausPrincipal Investigator

The Walton Centre

Liverpool L9 7LJ, United Kingdom

Recruiting
Site contact (verified)
Rhys DaviesPrincipal Investigator

Guy's and St. Thomas's NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Thomasin AndrewsPrincipal Investigator

St. George's Hospital

London SW17 0RE, United Kingdom

Recruiting
Site contact (verified)
Nayana LahiriPrincipal Investigator

University College of London

London WC1B SEH, United Kingdom

Recruiting
Site contact (verified)
Sarah TabriziPrincipal Investigator

Central Manchester University Hospitals NHS Foundation Trust

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
David CraufurdPrincipal Investigator

Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital

Newcastle upon Tyne NE3 3XT, United Kingdom

Recruiting
Site contact (verified)
Suresh KomatiPrincipal Investigator

St. Andrews Healthcare

Northampton NN1 5DG, United Kingdom

TERMINATED

Oxford Radcliffe Hospitals

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Andrea NemethPrincipal Investigator

Plymouth Hospitals NHS Trust

Plymouth PL6 8BX, United Kingdom

Recruiting
Site contact (verified)
Rupert NoadPrincipal Investigator

Poole Hospital

Poole BH15 2JB, United Kingdom

Recruiting
Site contact (verified)
John BurnPrincipal Investigator

Royal Berkshire NHS Foundation Trust

Reading RG1 5AN, United Kingdom

Recruiting
Site contact (verified)
Richard ArmstrongPrincipal Investigator

Sheffield Children's NHS Foundation Trust

Sheffield S10 2TH, United Kingdom

Recruiting
Site contact (verified)
Alisdair McNeillPrincipal Investigator

University Hospital Southampton

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Christopher KippsPrincipal Investigator

North Staffordshire Combined Healthcare NHS Trust

Stoke-on-Trent ST4 8HH, United Kingdom

Recruiting
Site contact (verified)
George El-NimrPrincipal Investigator

Avon and Wiltshire Mental Health Partnership

Swindon SN3 6BW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Hannah Antoniades

awp.research@nhs.net1173784266

How to Get in Touch

Noopur Modi

Sponsor contact

CONTACT

Info@Enroll-HD.org
Data sourced from ClinicalTrials.gov · Last verified: 2024-02