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

September 14, 2017 updated by: European Huntington's Disease Network

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz
      • Innsbruck, Austria, 6020
        • Universitätsklinik Innsbruck, Neurologie
  • Belgium
      • Brussels, Belgium, 1200
        • UCL-St Luc, Centre de génétique humaine
      • Gosselies, Belgium, B-6041
        • Institute of Pathology and Genetics (IPG)
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie
  • Czechia
      • Olomouc, Czechia, 772 00
        • Fakultni nemocnice Olomouc, Neurologicka klinika
      • Praha 2, Czechia, 12000
        • Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK
  • Denmark
      • Copenhagen Ø, Denmark, 2100
        • University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology
  • Finland
      • HUS, Finland, 29
        • Helsinki University Hospital, Dept. of Neurology
      • Helsinki, Finland, FIN-00101
        • The Family Federation of Finland Väestöliitto, Department of Medical Genetics
      • Kuopio, Finland, 1777 PL
        • Kuopio University Hospital, Neurology
      • Mariehamn, Finland, AX-22111
        • Ålands Hälso- och Sjukvård, Långvårdsenheten
      • Oulu, Finland, FIN-90220
        • Oulu University Hospital (OUH), Dept. of Neurology
      • Tampere, Finland, 33100
        • Suomen Terveystalo
      • Turku, Finland, 20521
        • Turku University Hospital, Dept. of Neurology
      • Turku, Finland, 20900
        • The Finnish Parkinson Association, Suvituuli
  • France
      • Amiens cedex, France, 80054
        • CHU d'Amiens - Hôpital Nord, Service de Neurologie
      • Angers cedex 9, France, 49933
        • CHU d'Angers, Service de Neurologie Charcot
      • Bordeaux cedex, France, 33076
        • Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)
      • Clermont-Ferrand, France, 63003
        • HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie
      • Créteil cedex, France, 94010
        • Hôpital Henri Mondor, Service de Neurologie
      • Lille cedex, France, 59037
        • Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement
      • Marseille cedex 5, France, 13385
        • CHU La Timone, Service de Neurologie (9e étage)
      • Paris, France, 75651
        • Hôpital La Pitié Salpétrière, Génétique & Inserm U679
      • Rouen cedex, France, 76031
        • CHU Rouen Charles Nicolle, Service de Neurologie
      • Strasbourg cedex, France, 67091
        • Hôpital Civil, Service de Neurologie
      • Toulouse cedex 03, France, 31059
        • Hôpital Purpan, INSERM U825, Pôle Neurosciences
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen, Neurologische Klinik
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie
      • Bochum, Germany, 44791
        • Ruhruniversität Bochum, Neurologie
      • Dinslaken, Germany, 46539
        • Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
      • Erlangen, Germany, 91054
        • Universtität Erlangen, Abteilung für Molekulare Neurologie
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg, Neurologie
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung
      • Hannover, Germany, 30625
        • Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover
      • Heiligenhafen, Germany, 23774
        • Psychatrium Gruppe AöR, Haus 2/1
      • Itzehoe, Germany, 25524
        • Schwerpunktpraxis Huntington, Neurologie-Psychiatrie
      • Marburg, Germany, 35039
        • Praxis
      • Marburg, Germany, 35039
        • Universität Marburg, Neurologie
      • München, Germany, 81675
        • Technische Universität München, Abteilung Neurologie
      • Münster, Germany, 48129
        • Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie
      • Taufkirchen, Germany, 84416
        • Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)
      • Ulm, Germany, 89081
        • University Hospital of Ulm, Dept. of Neurology
  • Italy
      • Bari, Italy, 70124
        • University of Bari, Dept. of Neurological and Psychiatric Sciences
      • Bologna, Italy, 40123
        • Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica
      • Brescia, Italy, 25125
        • Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica
      • Florence, Italy, 50134
        • University of Florence, Dip. di Scienze Neurologiche e Psichiatriche
      • Genova, Italy, 16132
        • Università di Genova, Dept. of Neurosciences
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia
      • Napoli, Italy, 80131
        • Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia
      • Pozzilli (IS), Italy, 86077
        • IRCCS Neuromed, U.O. Neurogenetica
      • Rome, Italy, 00139
        • Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS
      • Rome, Italy, 00168
        • Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale
  • Netherlands
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente, Dept. of Neurology
      • Groningen, Netherlands, 9700 RB
        • UMC Groningen, Neurology
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Centre (LUMC), Neurology K5-Q
      • Maastricht, Netherlands, 6202 AZ
        • MUMC, Dept. Neurology
  • Norway
      • Bergen, Norway, 5009
        • NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk
      • Oslo, Norway, 27
        • Rikshospitalet, Dept. of Medical Genetics
      • Oslo, Norway, 407
        • Ulleval University Hospital, Medical Genetics
      • Trondheim, Norway, 7006
        • St. Olavs Hospital HF, Neurology
  • Poland
      • Gdansk, Poland, 80-462
        • Specialistic Hospital in Gdansk, Dept. of Neurology
      • Katowice, Poland, 40-752
        • Medical University of Silesia, Dept. of Neurology
      • Krakow, Poland, 31-530
        • Krakowska Akademia Neurologii
      • Poznan, Poland, 60-806
        • Poznan University of Medical Sciences, Dept. of Social Medicine
      • Warsaw, Poland, 02-097
        • Medical University of Warsaw, Dept. of Neurology
      • Warsaw, Poland, 02-957
        • Institute of Psychiatry and Neurology, First Dept. of Neurology
  • Portugal
      • Coimbra, Portugal, 3004 561
        • Hospital de Coimbra, Neurology Dept.
      • Lisbon, Portugal, 1169-050
        • Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.
      • Lisbon, Portugal, 1649-028
        • Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.
      • Lisbon, Portugal, 2700
        • Hospital Fernando Fonseca, Neurology Dept.
      • Porto, Portugal, 4000
        • Hospital de São João, Neurology Dept.
      • Porto, Portugal, 4000
        • Hospital Geral de Santo António, Neurology Dept.
      • Vila Real, Portugal, 5000
        • Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.
  • Russian Federation
      • Moscow, Russian Federation, 125367
        • Huntington's Disease Society of Russia
  • Spain
      • Albacete, Spain, 2006
        • Complejo Hospitalario Universitario de Albacete, Neurología
      • Badajoz, Spain, 6080
        • Hospital Infanta Cristina, Neurología
      • Barcelona, Spain, 8035
        • Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas
      • Barcelona, Spain, 8036
        • Hospital Clínic i Provincial, Neurología
      • Barcelona, Spain, 8907
        • Hospital Bellvitge, Neurología
      • Burgos, Spain, 9006
        • Hospital General Yagüe, Neurology
      • Cádiz, Spain, 11009
        • Hospital Puerta del Mar, Neurología
      • Madrid, Spain, 28034
        • Centro Ramón y Cajal, Neurología
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz, Neurology
      • Madrid, Spain, 28044
        • Hospital Clínico de Madrid, Servicio de Neurología
      • Madrid, Spain, 28942
        • Hospital de Fuenlabrada, Neurology
      • Murcia, Spain, 30120
        • Hospital Virgen de la Arrixaca, Neurology
      • Oviedo, Spain
        • Hospital Central de Oviedo, Neurología
      • Palma de Mallorca, Spain, 7014
        • Hospital Son Dureta, Neurology
      • Pamplona, Spain, 31008
        • Hospital Virgen del Camino, Medical Genetics
      • San Sebastián, Spain, 20014
        • Hospital Donostia. Universidad del Pais Vasco, Neurociencias
      • Segovia, Spain, 40001
        • Hospital General de Segovia, Neurología
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío, Servicio de Neurología
      • Sevilla, Spain
        • Hospital Virgen Macarena, Neurología
      • Terrassa - Barcelona, Spain, 8221
        • Hospital Universitario Mutua de Terrassa, Neurologia - Investigación
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud, Neurology
      • Valencia, Spain, 46026
        • Hospital La Fe, Consultas Externas de Neurología
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universario, Department of Neurology
  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgren University Hospital, Dept. of Clinical Genetics
      • Lund, Sweden, 22185
        • Skåne Universitetssjukhus, Neurologiska kliniken
      • Stockholm, Sweden, 11 691
        • Neuroenheten Utsikten
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital - Huddinge Division, Neurology
      • Umeå, Sweden, 901 85
        • Norrlands Universitet Sjukhus, Dept. of Neurology
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital, Neurology
  • Switzerland
      • Bern, Switzerland, 3006
        • Neurologische Klinik des Inselspitals, Praxis
      • Lausanne, Switzerland, 1011
        • CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie
      • Zurich, Switzerland, 8091
        • University Hospital Zurich, Dept. of Neurology
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZA
        • Clinical Genetics Centre, Ground Floor, Ashgrove House
      • Birmingham, United Kingdom, B15 2FG
        • The Barberry Centre, Dept. of Psychiatry
      • Blandford Forum, United Kingdom, DT11 7DD
        • Blandford Hospital
      • Bristol, United Kingdom, BS16 1LE
        • Frenchay Hospital, Neurology Dept.
      • Cambridge, United Kingdom, CB2 0PY
        • Cambridge Centre for Brain Repair, Forvie Site
      • Cardiff, United Kingdom, CF10 3US
        • Cardiff University, Life Sciences Building
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School, Human Genetics Unit
      • Edinburgh, United Kingdom, EH4 2XU
        • Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology
      • Fife, United Kingdom, KY12 OSU
        • Queen Margaret Hospital
      • Glasgow, United Kingdom, G40 2DD
        • Scottish Huntington Association, Units 105/106
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hospital, Neurology Dept.
      • Hull, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital, Yorkshire Regional Genetics Service
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital
      • Leicester, United Kingdom, LE19 1XU
        • Leicestershire Partnership NHS Trust, EMD South School, OSL house
      • Liverpool, United Kingdom, L9 7LJ
        • The Walton Centre for Neurology and Neurosurgery
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital, Dept. of Neurology
      • London, United Kingdom, SW15 3SW
        • The Royal Hospital for Neuro-disability, Research and Development
      • London, United Kingdom, SW17 0RE
        • St George's Hospital Medical School, South West Thames Regional Genetics Unit
      • London, United Kingdom, WC1N 3BG
        • National Hospital for Neurology and Neurosurgery, Dept. for Neurology
      • Manchester, United Kingdom, M13 9WL
        • University of Manchester, Genetic Medicine, St. Mary's Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 3BZ
        • Institute of Human Genetics, International Centre for Life
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital, Dept. of Clinical Genetics
      • Plymouth, United Kingdom, PL6 8AH
        • Derriford Hospital, Dept. of Clinical Neuropsychology
      • Poole, United Kingdom, BH15 2JB
        • Poole Hospital Foundation Trust, Brain Injury Service
      • Preston, United Kingdom, PR2 9HT
        • Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital, Dept. of Clinical Genetics
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility
      • Stoke-on-Trent, United Kingdom, ST2 8LD
        • Bucknall Hospital, Neuropsychiatry Service
      • Swindon, United Kingdom, SN3 6BW
        • Victoria Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Huntington's Disease Network

Investigators

  • Principal Investigator: Bernhard Landwehrmeyer, Professor, University Hospital of Ulm / Dept. of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (ESTIMATE)

May 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGISTRY 3.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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