A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
NCT ID: NCT03761849
Last Updated: 2024-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
899 participants
INTERVENTIONAL
2019-01-23
2022-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RO7234292 Q8W
RO4234292 is administered intrathecally every 8 weeks.
RO7234292
Intrathecal injection
RO7234292 Q16W
RO7234292 is administered intrathecally every 16 weeks. Participants in this arm will also receive placebo at alternate weeks to keep the blind.
RO7234292
Intrathecal injection
Placebo
Intrathecal injection
Placebo
Placebo will be administered every 8 weeks by IT injection.
Placebo
Intrathecal injection
Interventions
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RO7234292
Intrathecal injection
Placebo
Intrathecal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Independence Scale (IS) score \>= 70
* Genetically confirmed disease by direct DNA testing with a CAP score \>400
* Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).
Exclusion Criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
25 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uab Medicine
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
Stanford Univ Medical Center
Palo Alto, California, United States
SC3 Research Group, Inc
Pasadena, California, United States
University of California Davis Medical System
Sacramento, California, United States
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, United States
Georgetown University; Research Division, Psychiatry
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dent Neurological Institute
Amherst, New York, United States
Columbia University
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston; McGovern Medical School
Houston, Texas, United States
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, United States
Evergreen Health Care Center
Kirkland, Washington, United States
Hospital Ramos Mejía
CABA, , Argentina
INEBA
Capital Federal, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
WESTMEAD HOSPITAL; Deparment of Neurology
Westmead, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital; Department of Neurology
Parkville, Victoria, Australia
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck, , Austria
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
Salzburg, , Austria
University of Alberta Hospital
Edmonton, Alberta, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada
True North Clinical Research-Halifax
Halifax, Nova Scotia, Canada
Centre for Movement Disorders
North YORK, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, Canada
Centro de Trastornos del Movimiento (CETRAM); CETRAM
Santiago, , Chile
Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit
Aarhus N, , Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, , Denmark
CHU Angers, Batiement Larrey 2, Neurologie
Angers, , France
Hopital Henri Mondor; Service de Neurologie
Créteil, , France
Hopital Roger Salengro Service de Neurologie
Lille, , France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, , France
Hopital Gui de Chauliac; Neurologie
Montpellier, , France
Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique
Paris, , France
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse, , France
Uniklinik RWTH Aachen; Klinik für Neurologie
Aachen, , Germany
Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie
Berlin, , Germany
St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration
Bochum, , Germany
German Center for Neurodegenerative Diseases (DZNE)
Bonn, , Germany
Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie
Erlangen, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen
Lübeck, , Germany
George-Huntington- Institut GmbH; Technologiepark Münster
Münster, , Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, , Germany
IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare
San Giovanni Rotondo, Apulia, Italy
IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Rome, Lazio, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genoa, Liguria, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica
Milan, Lombardy, Italy
A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche
Florence, Tuscany, Italy
Kuwana City Medical Center
Mie, , Japan
National Hospital Organization Niigata National Hospital
Niigata, , Japan
Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.
Okayama, , Japan
Osaka General Medical Center
Osaka, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
LUMC
Leiden, , Netherlands
Auckland DHB - Neurlogy Department; Neurology Department
Auckland, , New Zealand
New Zealand Brain Research Institute
Christchurch, , New Zealand
Wellington Hospital; Department of Neurology
Wellington, , New Zealand
Szpital Sw. Wojciecha; Oddzial Neurologiczny
Gdansk, , Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, Russia
Research Center of Neurology; Neurology Department #5
Moskva, Moscow Oblast, Russia
?linical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy
Kazan', Tatarstan Republic, Russia
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain
Hospital Universitario de Badajoz; Servicio de Neurología
Badajoz, , Spain
Hospital Clinic Servicio de Neurologia
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, , Spain
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, , Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Neurología
Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, , Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, , Spain
Universitätsspital Basel; Neurologie
Basel, , Switzerland
Neurozentrum Siloah
Gümligen, , Switzerland
Aberdeen Royal Infirmary; Medical Genectics
Aberdeen, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital
Cambridge, , United Kingdom
University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences
Cardiff, , United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
National Hospital For Neurology and Neurosurgery
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southhampton, , United Kingdom
Countries
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References
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Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.
Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GENERATION HD1
Identifier Type: OTHER
Identifier Source: secondary_id
BN40423
Identifier Type: -
Identifier Source: org_study_id
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