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Status unknownNCT01554033Updated Mar 19, 2012

Study of Huntington Patients in Connection With European Huntington's Disease Network (EHDN)

An observational study in Huntington Disease, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 1 Year to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
200
Ages
1 Year to 80 Years
Sex
All
01

Study summary

REGISTRY is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers. It is an open-ended study which will include as many eligible participants as willing to participate. The goal of the project is to collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers regardless of whether they display clinical symptoms and signs of the disease and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to:

  • obtain natural history data on a wide spectrum of HD mutation carriers and individuals who are part of an HD family
  • relate phenotypical characteristics

    • with genetic factors ('genetic modifiers')
    • with data derived from the study of body fluids (blood, urine - 'wet biomarker') and
    • imaging data ('dry biomarker')
  • expedite identification and recruitment of participants for clinical trials
  • develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care.
  • plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).
Read the detailed description

To collect prospective data on the phenotypical characteristics of HD mutation carriers regardless of whether they display clinical symptoms and signs of HD and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to;

  • obtain natural history data on a wide spectrum of HD patients, HD mutation carriers and individuals who are part of an HD family
  • relate phenotypical characteristics with

    • genetic factors ('genetic modifiers'),
    • data derived from the study of body fluids (blood, urine - 'wet biomarker') and
    • imaging data ('dry biomarker')
  • expedite identification and recruitment of participants for clinical trials
  • develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD, and which may also be potential outcome measures for use in future clinical trials and clinical care.
  • plan for future research studies (observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD).

To achieve these objectives, participants are asked to donate biosamples (blood and urine) for studies to identify genetic modifiers of HD and to establish and validate biological markers tracking the progressive course of HD; in this context a family history is requested as well in order to understand the relationships of clinical data sets and biosamples from related donors. In addition, non-mutation carrying family members of participants are asked to consider donating biosamples to serve as controls.

02

Conditions studied

  • Huntington Disease

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Keywords

  • European Huntington's Disease Network
  • Huntington patients in KOREA
03

In context

Huntington Disease

290 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 80 observational studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The following individuals may be eligible to participate

  • Individuals, confirmed HD mutation carrier
  • Manifest HD, without CAG testing
  • HD family member at-risk, without CAG testing
  • HD family member, non-HD mutation carrier
  • REGISTRY-CONTROL participants: companion/individual without HD history
  • REGISTRY-COMPANION (any of the above). Participants may be male or female and of any age. All participants must be able to provide consent for themselves, have a parent/guardian who can provide parental permission, or have an authorised legal representative who can provide consent.

Exclusion criteria

Exclusion Criteria:

  • Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Huntington's disease patients

    Huntington's disease patients and his(/her) family

  • age-sex matched control

    age-sex matched control about huntington patients

06

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Seoul National University Hospital
    Seoul, Seoul 110744, South Korea
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01554033
Collaborators
European Huntington's Disease Network
Responsible party
Sponsor
First posted
Mar 14, 2012
Start date
May 2009
Primary completion
May 2015 (estimated)
Completion
May 2015 (estimated)
Last update
Mar 19, 2012

Study contacts

Kim Manho, MD, PhD
Contact
kimmanho@snu.ac.kr
+822-2072-2193
Kim Manho, MD, PhD
study chair · Department of Neurology, Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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