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REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN) (REGISTRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590589
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
European Huntington's Disease Network

Study Description
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Brief Summary:

This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to:

  • obtain natural history data on many HD mutation carriers and individuals who are part of an HD family
  • relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)
  • 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

Condition or disease
Huntington Disease Huntington's Disease

Detailed Description:

REGISTRY integrates prospectively and systematically collected clinical research data (e.g. phenotypical clinical features, family history, demographical characteristics) with access to biological specimens (e.g. blood, urine) obtained 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).

REGISTRY is an open-ended study and eligible subjects are assessed at annual study visits on the phenotypical characteristics of HD 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). At each study visit, general clinical, motor function, behavior, cognitive, Health Economics, Quality of Life assessments are administered. In addition, participants are given the option to consent to the donation of biosamples for the purposes of mutation (CAG repeat length) testing and for research to identify biological modifiers and markers of HD. Biological specimens and phenotypical data are made available to qualified scientists whose projects are reviewed and approved by the Scientific and Bioethical Advisory Committee (SBAC) of EHDN. Successful applicants agree to accept the EHDN policies surrounding the use of the data/materials provided and publication of results (see data sharing and publication policies of EHDN, attached). Research projects should aim to advance scientific knowledge towards establishing clinically effective treatments that delay onset and/or slow the progression of the disease.

Study Design
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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)
Study Start Date : June 2004
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
REGISTRY participants

Individuals

  • with manifest HD
  • unaffected but known to carry the HD mutation
  • unaffected but at risk of carrying the HD mutation
  • from HD families known not to carry the HD mutation
  • from outside HD families acting as control research participants (e.g., spouses)


Outcome Measures
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Primary Outcome Measures :
  1. Phenotypical characteristics of HD [ Time Frame: 13 years ]
    The goal of the project is to collect longitudinal data on the phenotypical characteristics of HD gene mutation carriers.


Biospecimen Retention:   Samples With DNA
  • DNA from whole blood
  • DNA
  • Lymphoblastoid cell lines
  • Urine

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

REGISTRY-HD participants include those who are willing to participate in regular (annual) evaluations conducted by the investigators and have a diagnosis of HD, are HD mutation carriers (but who do not meet criteria for a diagnosis of HD) or persons at risk for HD (first and second degree relatives of people affected by HD), are non-HD mutation carrier relatives. Spouses of participants may take part as REGISTRY-CONTROLS.

Inclusion Criteria:

The following individuals may be eligible to participate

  • Individuals, confirmed HD mutation carrier
  • Manifest HD, without mutation (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).

Exclusion Criteria:

  • Participants who are unable to understand the study protocol or unable to give informed consent, and have no legal representative.
  • Participants with choreic movement disorder other than HD. (EHDN provides a Registry-like tool to record findings in patients affected with choreatic movement disorders other than HD under the label "Neuroacanthocytosis"; www.euro-hd.net/html/na/registry).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590589


Locations
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Sponsors and Collaborators
European Huntington's Disease Network
Investigators
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Principal Investigator: Bernhard Landwehrmeyer, Professor University Hospital of Ulm / Dept. of Neurology
More Information
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Additional Information:
EHDN  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Huntington's Disease Network
ClinicalTrials.gov Identifier: NCT01590589    
Other Study ID Numbers: REGISTRY 3.0
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by European Huntington's Disease Network:
Huntington Disease
European HD Network
Cohort
REGISTRY
EHDN
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders