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A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Primary Purpose

Huntingtons Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RO7234292
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntingtons Disease focused on measuring HD, RG6042, intrathecal, ASO, antisense oligonucleotide

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Manifest HD diagnosis, defined as a DCL score of 4
  • 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:

  • Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug

Sites / Locations

  • Uab Medicine
  • Barrow Neurological Institute
  • University of California San Diego
  • Stanford Univ Medical Center
  • SC3 Research Group, Inc
  • University of California Davis Medical System
  • CenExel Rocky Mountain Clinical Research, LLC
  • Georgetown University; Research Division, Psychiatry
  • University of South Florida
  • Northwestern University
  • John Hopkins University School of Medicine
  • Beth Israel Deaconess Medical Center
  • Washington University School of Medicine
  • Dent Neurological Institute
  • Columbia University
  • University of Pittsburgh
  • Vanderbilt University Medical Center
  • The University of Texas Health Science Center at Houston; McGovern Medical School
  • University of Utah Clinical Neurosciences Center
  • Evergreen Health Care Center
  • Hospital Ramos Mejía
  • INEBA
  • Hospital Britanico de Buenos Aires
  • WESTMEAD HOSPITAL; Deparment of Neurology
  • Monash Medical Centre
  • Royal Melbourne Hospital; Department of Neurology
  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
  • University of Alberta Hospital
  • University of British Columbia Hospital; Division of Neurology
  • True North Clinical Research-Halifax
  • Centre for Movement Disorders
  • Ottawa Hospital Research Institute
  • Centre Hospitalier de l'Université de Montréal (CHUM)
  • Centro de Trastornos del Movimiento (CETRAM); CETRAM
  • Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit
  • Rigshospitalet, Hukommelsesklinikken
  • CHU Angers, Batiement Larrey 2, Neurologie
  • Hopital Henri Mondor; Service de Neurologie
  • Hopital Roger Salengro; Service de Neurologie
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique
  • CHU toulouse - Hôpital Purpan; Departement de Neurologie
  • Uniklinik RWTH Aachen; Klinik für Neurologie
  • Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie
  • St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration
  • German Center for Neurodegenerative Diseases (DZNE)
  • Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen
  • George-Huntington- Institut GmbH; Technologiepark Münster
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica
  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica
  • IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare
  • A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche
  • National Hospital Organization Sagamihara National Hospital
  • Kuwana City Medical Center
  • National Hospital Organization Niigata National Hospital
  • Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.
  • Osaka General Medical Center
  • National Center of Neurology and Psychiatry
  • Universitair Medisch Centrum Groningen
  • LUMC
  • Auckland DHB - Neurlogy Department; Neurology Department
  • New Zealand Brain Research Institute
  • Wellington Hospital; Department of Neurology
  • Szpital Sw. Wojciecha; Oddzial Neurologiczny
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Instytut Psychiatrii i Neurologii
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • Research Center of Neurology; Neurology Department #5
  • Сlinical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy
  • Hospital de Cruces; Servicio de Neurologia
  • Hospital Universitario de Badajoz; Servicio de Neurología
  • Hospital Clinic Servicio de Neurologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Hospital Universitario de Burgos. Servicio de Neurología
  • Hospital Ramon y Cajal; Servicio de Neurologia
  • Fundacion Jimenez Diaz; Servicio de Neurología
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Universitätsspital Basel; Neurologie
  • Neurozentrum Siloah
  • Aberdeen Royal Infirmary; Medical Genectics
  • Queen Elizabeth Hospital
  • Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital
  • University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences
  • Queen Elizabeth University Hospital Glasgow
  • Leeds General Infirmary
  • National Hospital For Neurology and Neurosurgery
  • Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine
  • John Radcliffe Hospital
  • Royal Hallamshire Hospital
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RO7234292 Q8W

RO7234292 Q16W

Placebo

Arm Description

RO4234292 is administered intrathecally every 8 weeks.

RO7234292 is administered intrathecally every 16 weeks. Participants in this arm will also receive placebo at alternate weeks to keep the blind.

Placebo will be administered every 8 weeks by IT injection.

Outcomes

Primary Outcome Measures

Change from Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS)
Change From Baseline in the TFC Score

Secondary Outcome Measures

Change From Baseline in Total Motor Score (TMS)
Change From Baseline in Symbol Digit Modalities Test (SDMT)
Change From Baseline in Stroop Word Reading (SWR) Test
Change From Baseline in the Clinical Global Impression, Severity Scale (CGI-S)
Percentage of Patients with a Decrease From Baseline of >=1 point on the TFC
Percentage of Patients With a Decline From Baseline of >=1.2 Points on the cUHDRS
Percentage of Patients With an Unchanged or Improved Score on the Clinical Global Impression, Change Scale (CGI-C) Score
Percentage of Participants with Adverse Events
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Concentration of RO7234292 in Plasma
Trough Concentration of RO7234292 in CSF
Incidence of Anti-Drug Antibodies (ADAs)
Titer and Antibody Subtype, determined if ADAs are Identified
Change From Baseline in CSF mHTT Protein Level
Change From Baseline in Whole and Regional Brain Volumes, as detrmined by structural magnetic resonance imaging (MRI)
Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level

Full Information

First Posted
November 30, 2018
Last Updated
September 21, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03761849
Brief Title
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
Official Title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntingtons Disease
Keywords
HD, RG6042, intrathecal, ASO, antisense oligonucleotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
899 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RO7234292 Q8W
Arm Type
Experimental
Arm Description
RO4234292 is administered intrathecally every 8 weeks.
Arm Title
RO7234292 Q16W
Arm Type
Experimental
Arm Description
RO7234292 is administered intrathecally every 16 weeks. Participants in this arm will also receive placebo at alternate weeks to keep the blind.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered every 8 weeks by IT injection.
Intervention Type
Drug
Intervention Name(s)
RO7234292
Other Intervention Name(s)
Tominersen
Intervention Description
Intrathecal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intrathecal injection
Primary Outcome Measure Information:
Title
Change from Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS)
Time Frame
Baselined, Week 101
Title
Change From Baseline in the TFC Score
Time Frame
Baseline, Week 101
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Motor Score (TMS)
Time Frame
Baseline, Week 101
Title
Change From Baseline in Symbol Digit Modalities Test (SDMT)
Time Frame
Baseline, Week 101
Title
Change From Baseline in Stroop Word Reading (SWR) Test
Time Frame
Baseline, Week 101
Title
Change From Baseline in the Clinical Global Impression, Severity Scale (CGI-S)
Time Frame
Baseline, Week 101
Title
Percentage of Patients with a Decrease From Baseline of >=1 point on the TFC
Time Frame
Baseline, Week101
Title
Percentage of Patients With a Decline From Baseline of >=1.2 Points on the cUHDRS
Time Frame
Baseline, Week 101
Title
Percentage of Patients With an Unchanged or Improved Score on the Clinical Global Impression, Change Scale (CGI-C) Score
Time Frame
Baseline to Week 101
Title
Percentage of Participants with Adverse Events
Time Frame
Up to 117 Weeks (29 months)
Title
Change From Baseline in Montreal Cognitive Assessment (MoCA)
Time Frame
Screening, Baseline, Weeks 5, 21, 37, 53, 69, 85 and 101 and early treatment termination
Title
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
Screening, Baseline, Weeks 5, 13, 21, 29, 37, 45, 53, 61, 69, 77, 85, 93, 101, 117, end of treatment for early treatment termination and at early treatment termination
Title
Concentration of RO7234292 in Plasma
Time Frame
Baseline, Weeks 13, 21, 37, 53, 69, 85, and 101 and early treatment termination
Title
Trough Concentration of RO7234292 in CSF
Time Frame
Baseline, Weeks 13, 21, 37, 53, 69, 85, and 101 and early treatment termination
Title
Incidence of Anti-Drug Antibodies (ADAs)
Time Frame
Baseline, Weeks 13, 21, 37, 53, 69, 85, and 101 and early treatment termination and safety follow-up visit
Title
Titer and Antibody Subtype, determined if ADAs are Identified
Time Frame
Baseline, Weeks 13, 21, 37, 53, 69, 85, and 101 and early treatment termination and safety follow-up visit
Title
Change From Baseline in CSF mHTT Protein Level
Time Frame
Baseline, Week 101
Title
Change From Baseline in Whole and Regional Brain Volumes, as detrmined by structural magnetic resonance imaging (MRI)
Time Frame
Baseline, Week 101
Title
Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level
Time Frame
Baseline, Week 101

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Manifest HD diagnosis, defined as a DCL score of 4 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: Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Uab Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Univ Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
SC3 Research Group, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California Davis Medical System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CenExel Rocky Mountain Clinical Research, LLC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Georgetown University; Research Division, Psychiatry
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
The University of Texas Health Science Center at Houston; McGovern Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Clinical Neurosciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Evergreen Health Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Hospital Ramos Mejía
City
Caba
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
INEBA
City
Capital Federal
ZIP/Postal Code
C1192AAX
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1284AEB
Country
Argentina
Facility Name
WESTMEAD HOSPITAL; Deparment of Neurology
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Neurology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
University of British Columbia Hospital; Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
True North Clinical Research-Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
Centre for Movement Disorders
City
North York
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C2
Country
Canada
Facility Name
Centro de Trastornos del Movimiento (CETRAM); CETRAM
City
LO Espejo
ZIP/Postal Code
9120000
Country
Chile
Facility Name
Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet, Hukommelsesklinikken
City
Koebenhavn Oe
ZIP/Postal Code
2100
Country
Denmark
Facility Name
CHU Angers, Batiement Larrey 2, Neurologie
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Henri Mondor; Service de Neurologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Roger Salengro; Service de Neurologie
City
Lille
Country
France
Facility Name
CHU de la Timone - Hopital d Adultes; Service de Neurologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU toulouse - Hôpital Purpan; Departement de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Uniklinik RWTH Aachen; Klinik für Neurologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
German Center for Neurodegenerative Diseases (DZNE)
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
George-Huntington- Institut GmbH; Technologiepark Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare
City
San Giovanni Rotondo (FG)
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche
City
Firenze
State/Province
Toscana
Country
Italy
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Kuwana City Medical Center
City
Mie
ZIP/Postal Code
511-0061
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Facility Name
Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Auckland DHB - Neurlogy Department; Neurology Department
City
Auckland
Country
New Zealand
Facility Name
New Zealand Brain Research Institute
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Wellington Hospital; Department of Neurology
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Szpital Sw. Wojciecha; Oddzial Neurologiczny
City
Gdańsk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Research Center of Neurology; Neurology Department #5
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Сlinical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario de Badajoz; Servicio de Neurología
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Hospital Clinic Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de Burgos. Servicio de Neurología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitätsspital Basel; Neurologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Neurozentrum Siloah
City
Gümligen
ZIP/Postal Code
3073
Country
Switzerland
Facility Name
Aberdeen Royal Infirmary; Medical Genectics
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0SP
Country
United Kingdom
Facility Name
University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital Glasgow
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
National Hospital For Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southhampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31381524
Citation
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.
Results Reference
derived
PubMed Identifier
30776019
Citation
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.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

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