REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)
NCT ID: NCT01590589
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10000 participants
OBSERVATIONAL
2004-06-30
2017-06-30
Brief Summary
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* 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
Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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).
ALL
Yes
Sponsors
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European Huntington's Disease Network
NETWORK
Responsible Party
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Principal Investigators
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Bernhard Landwehrmeyer, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Ulm / Dept. of Neurology
Locations
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Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz
Graz, , Austria
Universitätsklinik Innsbruck, Neurologie
Innsbruck, , Austria
UCL-St Luc, Centre de génétique humaine
Brussels, , Belgium
Institute of Pathology and Genetics (IPG)
Gosselies, , Belgium
Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie
Leuven, , Belgium
Fakultní nemocnice Olomouc, Neurologická klinika
Olomouc, , Czechia
Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK
Prague, , Czechia
University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology
Copenhagen Ø, , Denmark
The Family Federation of Finland Väestöliitto, Department of Medical Genetics
Helsinki, , Finland
Helsinki University Hospital, Dept. of Neurology
HUS, , Finland
Kuopio University Hospital, Neurology
Kuopio, , Finland
Ålands Hälso- och Sjukvård, Långvårdsenheten
Mariehamn, , Finland
Oulu University Hospital (OUH), Dept. of Neurology
Oulu, , Finland
Suomen Terveystalo
Tampere, , Finland
Turku University Hospital, Dept. of Neurology
Turku, , Finland
The Finnish Parkinson Association, Suvituuli
Turku, , Finland
CHU d'Amiens - Hôpital Nord, Service de Neurologie
Amiens, , France
CHU d'Angers, Service de Neurologie Charcot
Angers, , France
Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)
Bordeaux, , France
HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie
Clermont-Ferrand, , France
Hôpital Henri Mondor, Service de Neurologie
Créteil, , France
Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement
Lille, , France
CHU La Timone, Service de Neurologie (9e étage)
Marseille, , France
Hôpital La Pitié Salpétrière, Génétique & Inserm U679
Paris, , France
CHU Rouen Charles Nicolle, Service de Neurologie
Rouen, , France
Hôpital Civil, Service de Neurologie
Strasbourg, , France
Hôpital Purpan, INSERM U825, Pôle Neurosciences
Toulouse, , France
Universitätsklinikum Aachen, Neurologische Klinik
Aachen, , Germany
Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie
Berlin, , Germany
Ruhruniversität Bochum, Neurologie
Bochum, , Germany
Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik
Dinslaken, , Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie
Dresden, , Germany
Universtität Erlangen, Abteilung für Molekulare Neurologie
Erlangen, , Germany
Universitätsklinikum Freiburg, Neurologie
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung
Hamburg, , Germany
Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover
Hanover, , Germany
Psychatrium Gruppe AöR, Haus 2/1
Heiligenhafen, , Germany
Schwerpunktpraxis Huntington, Neurologie-Psychiatrie
Itzehoe, , Germany
Praxis
Marburg, , Germany
Universität Marburg, Neurologie
Marburg, , Germany
Technische Universität München, Abteilung Neurologie
München, , Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie
Münster, , Germany
Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)
Taufkirchen, , Germany
University Hospital of Ulm, Dept. of Neurology
Ulm, , Germany
University of Bari, Dept. of Neurological and Psychiatric Sciences
Bari, , Italy
Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica
Brescia, , Italy
University of Florence, Dip. di Scienze Neurologiche e Psichiatriche
Florence, , Italy
Università di Genova, Dept. of Neurosciences
Genova, , Italy
Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases
Milan, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia
Milan, , Italy
Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17
Napoli, , Italy
Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia
Pisa, , Italy
IRCCS Neuromed, U.O. Neurogenetica
Pozzilli (IS), , Italy
Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS
Rome, , Italy
Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale
Rome, , Italy
Medisch Spectrum Twente, Dept. of Neurology
Enschede, , Netherlands
UMC Groningen, Neurology
Groningen, , Netherlands
Leiden University Medical Centre (LUMC), Neurology K5-Q
Leiden, , Netherlands
MUMC, Dept. Neurology
Maastricht, , Netherlands
NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk
Bergen, , Norway
Rikshospitalet, Dept. of Medical Genetics
Oslo, , Norway
Ulleval University Hospital, Medical Genetics
Oslo, , Norway
St. Olavs Hospital HF, Neurology
Trondheim, , Norway
Specialistic Hospital in Gdansk, Dept. of Neurology
Gdansk, , Poland
Medical University of Silesia, Dept. of Neurology
Katowice, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
Poznan University of Medical Sciences, Dept. of Social Medicine
Poznan, , Poland
Medical University of Warsaw, Dept. of Neurology
Warsaw, , Poland
Institute of Psychiatry and Neurology, First Dept. of Neurology
Warsaw, , Poland
Hospital de Coimbra, Neurology Dept.
Coimbra, , Portugal
Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.
Lisbon, , Portugal
Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.
Lisbon, , Portugal
Hospital Fernando Fonseca, Neurology Dept.
Lisbon, , Portugal
Hospital de São João, Neurology Dept.
Porto, , Portugal
Hospital Geral de Santo António, Neurology Dept.
Porto, , Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.
Vila Real, , Portugal
Huntington's Disease Society of Russia
Moscow, , Russia
Complejo Hospitalario Universitario de Albacete, Neurología
Albacete, , Spain
Hospital Infanta Cristina, Neurología
Badajoz, , Spain
Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas
Barcelona, , Spain
Hospital Clínic i Provincial, Neurología
Barcelona, , Spain
Hospital Bellvitge, Neurología
Barcelona, , Spain
Hospital General Yagüe, Neurology
Burgos, , Spain
Hospital Puerta del Mar, Neurología
Cadiz, , Spain
Centro Ramón y Cajal, Neurología
Madrid, , Spain
Fundación Jiménez Díaz, Neurology
Madrid, , Spain
Hospital Clínico de Madrid, Servicio de Neurología
Madrid, , Spain
Hospital de Fuenlabrada, Neurology
Madrid, , Spain
Hospital Virgen de la Arrixaca, Neurology
Murcia, , Spain
Hospital Central de Oviedo, Neurología
Oviedo, , Spain
Hospital Son Dureta, Neurology
Palma de Mallorca, , Spain
Hospital Virgen del Camino, Medical Genetics
Pamplona, , Spain
Hospital Donostia. Universidad del Pais Vasco, Neurociencias
San Sebastián, , Spain
Hospital General de Segovia, Neurología
Segovia, , Spain
Hospital Universitario Virgen del Rocío, Servicio de Neurología
Seville, , Spain
Hospital Virgen Macarena, Neurología
Seville, , Spain
Hospital Universitario Mutua de Terrassa, Neurologia - Investigación
Terrassa - Barcelona, , Spain
Hospital Virgen de la Salud, Neurology
Toledo, , Spain
Hospital La Fe, Consultas Externas de Neurología
Valencia, , Spain
Hospital Clinico Universario, Department of Neurology
Zaragoza, , Spain
Sahlgren University Hospital, Dept. of Clinical Genetics
Gothenburg, , Sweden
Skåne Universitetssjukhus, Neurologiska kliniken
Lund, , Sweden
Neuroenheten Utsikten
Stockholm, , Sweden
Karolinska University Hospital - Huddinge Division, Neurology
Stockholm, , Sweden
Norrlands Universitet Sjukhus, Dept. of Neurology
Umeå, , Sweden
Uppsala University Hospital, Neurology
Uppsala, , Sweden
Neurologische Klinik des Inselspitals, Praxis
Bern, , Switzerland
CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie
Lausanne, , Switzerland
University Hospital Zurich, Dept. of Neurology
Zurich, , Switzerland
Clinical Genetics Centre, Ground Floor, Ashgrove House
Aberdeen, , United Kingdom
The Barberry Centre, Dept. of Psychiatry
Birmingham, , United Kingdom
Blandford Hospital
Blandford Forum, , United Kingdom
Frenchay Hospital, Neurology Dept.
Bristol, , United Kingdom
Cambridge Centre for Brain Repair, Forvie Site
Cambridge, , United Kingdom
Cardiff University, Life Sciences Building
Cardiff, , United Kingdom
Ninewells Hospital and Medical School, Human Genetics Unit
Dundee, , United Kingdom
Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics
Edinburgh, , United Kingdom
Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology
Exeter, , United Kingdom
Queen Margaret Hospital
Fife, , United Kingdom
Scottish Huntington Association, Units 105/106
Glasgow, , United Kingdom
Gloucestershire Royal Hospital, Neurology Dept.
Gloucester, , United Kingdom
Chapel Allerton Hospital, Yorkshire Regional Genetics Service
Hull, , United Kingdom
Chapel Allerton Hospital
Leeds, , United Kingdom
Leicestershire Partnership NHS Trust, EMD South School, OSL house
Leicester, , United Kingdom
The Walton Centre for Neurology and Neurosurgery
Liverpool, , United Kingdom
Guy's Hospital, Dept. of Neurology
London, , United Kingdom
The Royal Hospital for Neuro-disability, Research and Development
London, , United Kingdom
St George's Hospital Medical School, South West Thames Regional Genetics Unit
London, , United Kingdom
National Hospital for Neurology and Neurosurgery, Dept. for Neurology
London, , United Kingdom
University of Manchester, Genetic Medicine, St. Mary's Hospital
Manchester, , United Kingdom
Institute of Human Genetics, International Centre for Life
Newcastle upon Tyne, , United Kingdom
Churchill Hospital, Dept. of Clinical Genetics
Oxford, , United Kingdom
Derriford Hospital, Dept. of Clinical Neuropsychology
Plymouth, , United Kingdom
Poole Hospital Foundation Trust, Brain Injury Service
Poole, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital
Preston, , United Kingdom
Sheffield Children's Hospital, Dept. of Clinical Genetics
Sheffield, , United Kingdom
Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility
Southampton, , United Kingdom
Bucknall Hospital, Neuropsychiatry Service
Stoke-on-Trent, , United Kingdom
Victoria Centre
Swindon, , United Kingdom
Countries
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References
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Rickards H, De Souza J, van Walsem M, van Duijn E, Simpson SA, Squitieri F, Landwehrmeyer B; European Huntington's Disease Network. Factor analysis of behavioural symptoms in Huntington's disease. J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):411-2. doi: 10.1136/jnnp.2009.181149. Epub 2010 Apr 14.
Orth M, Handley OJ, Schwenke C, Dunnett SB, Craufurd D, Ho AK, Wild E, Tabrizi SJ, Landwehrmeyer GB; Investigators of the European Huntington's Disease Network. Observing Huntington's Disease: the European Huntington's Disease Network's REGISTRY. PLoS Curr. 2010 Sep 28;2:RRN1184. doi: 10.1371/currents.RRN1184.
Orth M; European Huntington's Disease Network; Handley OJ, Schwenke C, Dunnett S, Wild EJ, Tabrizi SJ, Landwehrmeyer GB. Observing Huntington's disease: the European Huntington's Disease Network's REGISTRY. J Neurol Neurosurg Psychiatry. 2011 Dec;82(12):1409-12. doi: 10.1136/jnnp.2010.209668. Epub 2010 Nov 19. No abstract available.
Busse M, Al-Madfai DH, Kenkre J, Landwehrmeyer GB, Bentivoglio A, Rosser A; European Huntington's Disease Network. Utilisation of Healthcare and Associated Services in Huntington's disease: a data mining study. PLoS Curr. 2011 Jan 21;3:RRN1206. doi: 10.1371/currents.RRN1206.
Lopez-Sendon JL, Royuela A, Trigo P, Orth M, Lange H, Reilmann R, Keylock J, Rickards H, Piacentini S, Squitieri F, Landwehrmeyer B, Witjes-Ane MN, Jurgens CK, Roos RA, Abraira V, de Yebenes JG; European HD Network. What is the impact of education on Huntington's disease? Mov Disord. 2011 Jul;26(8):1489-95. doi: 10.1002/mds.23385. Epub 2011 Mar 22.
Ho AK, Hocaoglu MB; European Huntington's Disease Network Quality of Life Working Group. Impact of Huntington's across the entire disease spectrum: the phases and stages of disease from the patient perspective. Clin Genet. 2011 Sep;80(3):235-9. doi: 10.1111/j.1399-0004.2011.01748.x. Epub 2011 Aug 4.
Quarrell OW, Handley O, O'Donovan K, Dumoulin C, Ramos-Arroyo M, Biunno I, Bauer P, Kline M, Landwehrmeyer GB; European Huntington's Disease Network. Discrepancies in reporting the CAG repeat lengths for Huntington's disease. Eur J Hum Genet. 2012 Jan;20(1):20-6. doi: 10.1038/ejhg.2011.136. Epub 2011 Aug 3.
Saft C, Epplen JT, Wieczorek S, Landwehrmeyer GB, Roos RA, de Yebenes JG, Dose M, Tabrizi SJ, Craufurd D; REGISTRY Investigators of the European Huntington's Disease Network; Arning L. NMDA receptor gene variations as modifiers in Huntington disease: a replication study. PLoS Curr. 2011 Oct 4;3:RRN1247. doi: 10.1371/currents.RRN1247.
Rickards H, De Souza J, Crooks J, van Walsem MR, van Duijn E, Landwehrmeyer B, Squitieri F, Simpson SA; European Huntington's Disease Network. Discriminant analysis of Beck Depression Inventory and Hamilton Rating Scale for Depression in Huntington's disease. J Neuropsychiatry Clin Neurosci. 2011 Fall;23(4):399-402. doi: 10.1176/jnp.23.4.jnp399.
Lee JM, Ramos EM, Lee JH, Gillis T, Mysore JS, Hayden MR, Warby SC, Morrison P, Nance M, Ross CA, Margolis RL, Squitieri F, Orobello S, Di Donato S, Gomez-Tortosa E, Ayuso C, Suchowersky O, Trent RJ, McCusker E, Novelletto A, Frontali M, Jones R, Ashizawa T, Frank S, Saint-Hilaire MH, Hersch SM, Rosas HD, Lucente D, Harrison MB, Zanko A, Abramson RK, Marder K, Sequeiros J, Paulsen JS; PREDICT-HD study of the Huntington Study Group (HSG); Landwehrmeyer GB; REGISTRY study of the European Huntington's Disease Network; Myers RH; HD-MAPS Study Group; MacDonald ME, Gusella JF; COHORT study of the HSG. CAG repeat expansion in Huntington disease determines age at onset in a fully dominant fashion. Neurology. 2012 Mar 6;78(10):690-5. doi: 10.1212/WNL.0b013e318249f683. Epub 2012 Feb 8.
Henley SM, Ridgway GR, Scahill RI, Kloppel S, Tabrizi SJ, Fox NC, Kassubek J; EHDN Imaging Working Group. Pitfalls in the use of voxel-based morphometry as a biomarker: examples from huntington disease. AJNR Am J Neuroradiol. 2010 Apr;31(4):711-9. doi: 10.3174/ajnr.A1939. Epub 2009 Dec 24.
Aziz NA, Jurgens CK, Landwehrmeyer GB; EHDN Registry Study Group; van Roon-Mom WM, van Ommen GJ, Stijnen T, Roos RA. Normal and mutant HTT interact to affect clinical severity and progression in Huntington disease. Neurology. 2009 Oct 20;73(16):1280-5. doi: 10.1212/WNL.0b013e3181bd1121. Epub 2009 Sep 23.
Stanislawska-Sachadyn A, Krzeminski M, Zielonka D, Krygier M, Zietkiewicz E, Slawek J, Limon J; REGISTRY investigators of the European Huntington's Disease Network (EHDN). Sex contribution to average age at onset of Huntington's disease depends on the number of (CAG)n repeats. Sci Rep. 2024 Jul 8;14(1):15729. doi: 10.1038/s41598-024-64105-5.
Youssov K, Audureau E, Vandendriessche H, Morgado G, Layese R, Goizet C, Verny C, Bourhis ML, Bachoud-Levi AC. The burden of Huntington's disease: A prospective longitudinal study of patient/caregiver pairs. Parkinsonism Relat Disord. 2022 Oct;103:77-84. doi: 10.1016/j.parkreldis.2022.08.023. Epub 2022 Aug 24.
McAllister B, Gusella JF, Landwehrmeyer GB, Lee JM, MacDonald ME, Orth M, Rosser AE, Williams NM, Holmans P, Jones L, Massey TH; REGISTRY Investigators of the European Huntington's Disease Network. Timing and Impact of Psychiatric, Cognitive, and Motor Abnormalities in Huntington Disease. Neurology. 2021 May 11;96(19):e2395-e2406. doi: 10.1212/WNL.0000000000011893. Epub 2021 Mar 25.
Cubo E, Ramos-Arroyo MA, Martinez-Horta S, Martinez-Descalls A, Calvo S, Gil-Polo C; European HD Network. Clinical manifestations of intermediate allele carriers in Huntington disease. Neurology. 2016 Aug 9;87(6):571-8. doi: 10.1212/WNL.0000000000002944. Epub 2016 Jul 8.
Related Links
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Other Identifiers
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REGISTRY 3.0
Identifier Type: -
Identifier Source: org_study_id