Back to resultsGENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.
Primary Purpose
Huntington Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tominersen 60 mg
Placebo
Tominersen 100 mg
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring Prodromal and Early Manifest Huntington's Disease
Eligibility Criteria
Key Inclusion Criteria Signed study companion consent form. A study companion is required for all participants. HD gene expansion mutation carrier status. CAP score of 400-500, inclusive, where CAP is calculated as follows: Age x (CAG repeat length -33.66) -Prodromal HD, defined as DCL 2 to 3, Total Motor Score (TMS) >6, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= 70, and TFC >/=8 (broadly equivalent to HD-ISS Stage 3) Companion Inclusion Criteria - HD gene expansion mutation carrier status. CAP score of 400-500, inclusive, where CAP is calculated as follows: Age x (CAG repeat length -33.66) Prodromal HD, defined as DCL 2 to 3, Total Motor Score (TMS) >6, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= 70, and TFC >/=8 (broadly equivalent to HD-ISS Stage 3) Signed study companion consent form. A study companion is required for all participants. Key Exclusion Criteria Current or previous use of an ASO (including small interfering RNA) or any HTT lowering therapy (including tominersen) Anti-platelet or anticoagulant therapy within 14 days prior to screening or anticipated use during the study, including, but not limited to, aspirin (unless </= 81 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, apixaban, and heparin History of gene therapy, cell transplantation, or brain surgery Hydrocephalus Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of study drug History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening
Sites / Locations
- Uab MedicineRecruiting
- Barrow Neurological InstituteRecruiting
- University of California San DiegoRecruiting
- University of California Davis Medical SystemRecruiting
- CenExel Rocky Mountain Clinical Research, LLCRecruiting
- Georgetown University; Research Division, PsychiatryRecruiting
- University of FloridaRecruiting
- University of South FloridaRecruiting
- Northwestern UniversityRecruiting
- John Hopkins University School of MedicineRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Dent Neurological InstituteRecruiting
- University of PittsburghRecruiting
- Vanderbilt University Medical CenterRecruiting
- Inland Northwest ResearchRecruiting
- CINMERecruiting
- Hospital Ramos MejíaRecruiting
- INEBARecruiting
- Hospital Britanico de Buenos AiresRecruiting
- WESTMEAD HOSPITAL; Deparment of NeurologyRecruiting
- Monash Medical CentreRecruiting
- Perron Institute for Neurological and Translational ScienceRecruiting
- Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer NeurologieRecruiting
- Rigshospitalet, HukommelsesklinikkenRecruiting
- CHU Angers, Batiement Larrey 2, NeurologieRecruiting
- Hopital Henri Mondor; Service de NeurologieRecruiting
- Hopital Roger Salengro Service de NeurologieRecruiting
- CHU toulouse - Hôpital Purpan; Departement de NeurologieRecruiting
- Uniklinik RWTH Aachen; Klinik für NeurologieRecruiting
- Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. NeuropsychiatrieRecruiting
- St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. NeurodegenerationRecruiting
- German Center for Neurodegenerative Diseases (DZNE)Recruiting
- Universitätsklinikum Erlangen, Abteilung Molekulare NeurologieRecruiting
- Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene ErkrankungenRecruiting
- Universitätsklinikum Ulm; Klinik für NeurologieRecruiting
- Ospedale Bellaria; Istituto delle Scienze NeurologicheRecruiting
- Azienda Ospedaliera Sant'Andrea; UOC NeurologiaRecruiting
- Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-NeurogeneticaRecruiting
- New Zealand Brain Research InstituteRecruiting
- Szpital Sw. Wojciecha; Oddzial NeurologicznyRecruiting
- Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii KRecruiting
- Instytut Psychiatrii i NeurologiiRecruiting
- Hospital de Santa Maria; Servico de NeurologiaRecruiting
- CNS - Campus NeurológicoRecruiting
- Hospital de Cruces; Servicio de NeurologiaRecruiting
- Hospital Universitario de Badajoz; Servicio de NeurologíaRecruiting
- Hospital de la Santa Creu i Sant Pau; Servicio de NeurologiaRecruiting
- Hospital Universitario de Burgos. Servicio de NeurologíaRecruiting
- Hospital Ramon y Cajal; Servicio de NeurologiaRecruiting
- Hospital Universitario Virgen Macarena; Servicio de NeurologiaRecruiting
- Hospital Universitario la Fe; Servicio de NeurologiaRecruiting
- Universitätsspital Basel; NeurologieRecruiting
- Neurozentrum SiloahRecruiting
- University Hospitals Birmingham NHS Foundation TrustRecruiting
- Addenbrookes HospitalRecruiting
- John Radcliffe Hospital; NeurosciencesRecruiting
- Chapel Allerton Hospital; Clinical GeneticsRecruiting
- UCL Hospital NHS TrustRecruiting
- Southampton University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Tominersen 60 mg
Placebo
Tominersen 100 mg
Arm Description
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events, with severity determined according to the Adverse Event Severity Grading Scale
Change from baseline in clinical laboratory results - Cerebrospinal fluid (CSF) White Blood Cell (WBC) (1/uL)
Change from baseline in clinical laboratory results Cerebrospinal fluid (CSF) protein (g/L)
Change in baseline in structural MRI assessing any new abnormalities including radiographic features consistent with hydrocephalus and other relevant MRI safety findings
Percentage change from baseline in geometric means of CSF mHTT protein levels at Month 9
Change from baseline in composite Unified Huntington's Disease Rating Scale (cUHDRS) Scores (non-U.S. sites) at 16 months
Change in scores on the scale
Change from baseline in Total Functional Capacity (TFC) Scores (U.S. sites) at 16 months
Change in scores on the scale
Secondary Outcome Measures
Change from baseline in MoCA Scores
Percentage of participants with suicidal ideation or behavior as assessed by C-SSRS score at each visit, including detailed focus on any individual cases identified as having severe ideation or behavior during the study conduct
Change from baseline at 16 months for the assessments of TFC (non-U.S. sites) Scores
Change from baseline at 16 months for the assessments of cUHDRS (U.S. sites) Scores
Change from baseline at 16 months for the assessments of Symbol Digit Modalities Test (SDMT) Scores
Change from Baseline at 16 Months for the Assessments of Stroop Word Reading (SWR) Scores
Change from baseline at 16 months for the assessments of Total Motor Score (TMS)
Change from baseline in CSF Neurofilament light Chain (NfL) levels at 16 months
Incidence of anti-drug antibodies (ADAs) at specified timepoints relative to the prevalence of ADAs at baseline
Titers determined if ADAs are identified
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05686551
Brief Title
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen in Individuals With Prodromal and Early Manifest Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
January 4, 2027 (Anticipated)
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
5. Study Description
Brief Summary
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Prodromal and Early Manifest Huntington's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tominersen 60 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Tominersen 100 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tominersen 60 mg
Intervention Description
60 mg tominersen administered intrathecally every 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered intrathecally every 16 weeks
Intervention Type
Drug
Intervention Name(s)
Tominersen 100 mg
Intervention Description
100 mg tominersen administered intrathecally every 16 weeks
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events, with severity determined according to the Adverse Event Severity Grading Scale
Time Frame
Up to Approximately 24 Months
Title
Change from baseline in clinical laboratory results - Cerebrospinal fluid (CSF) White Blood Cell (WBC) (1/uL)
Time Frame
From Baseline Visit (Day 1), and Months 4, 8, 9, 12, 16
Title
Change from baseline in clinical laboratory results Cerebrospinal fluid (CSF) protein (g/L)
Time Frame
From Baseline Visit (Day 1), and Months 4, 8, 9, 12, 16
Title
Change in baseline in structural MRI assessing any new abnormalities including radiographic features consistent with hydrocephalus and other relevant MRI safety findings
Time Frame
From Baseline, Months 4, 8, 12, 16 and Up to Approximately Month 36
Title
Percentage change from baseline in geometric means of CSF mHTT protein levels at Month 9
Time Frame
Baseline and Month 9
Title
Change from baseline in composite Unified Huntington's Disease Rating Scale (cUHDRS) Scores (non-U.S. sites) at 16 months
Description
Change in scores on the scale
Time Frame
Up to Approximately 16 Months
Title
Change from baseline in Total Functional Capacity (TFC) Scores (U.S. sites) at 16 months
Description
Change in scores on the scale
Time Frame
Baseline and 16 Months
Secondary Outcome Measure Information:
Title
Change from baseline in MoCA Scores
Time Frame
From Baseline, Months 4, 8, 12, 16 and up to approximately Month 36
Title
Percentage of participants with suicidal ideation or behavior as assessed by C-SSRS score at each visit, including detailed focus on any individual cases identified as having severe ideation or behavior during the study conduct
Time Frame
Up to Approximately 24 Months
Title
Change from baseline at 16 months for the assessments of TFC (non-U.S. sites) Scores
Time Frame
Baseline to 16 Months
Title
Change from baseline at 16 months for the assessments of cUHDRS (U.S. sites) Scores
Time Frame
Baseline to 16 Months
Title
Change from baseline at 16 months for the assessments of Symbol Digit Modalities Test (SDMT) Scores
Time Frame
Baseline to 16 Months
Title
Change from Baseline at 16 Months for the Assessments of Stroop Word Reading (SWR) Scores
Time Frame
Baseline to 16 Months
Title
Change from baseline at 16 months for the assessments of Total Motor Score (TMS)
Time Frame
Baseline to 16 Months
Title
Change from baseline in CSF Neurofilament light Chain (NfL) levels at 16 months
Time Frame
Baseline to 16 Months
Title
Incidence of anti-drug antibodies (ADAs) at specified timepoints relative to the prevalence of ADAs at baseline
Time Frame
From Baseline, Months 4, 8, 12, 16 and Up to Approximately Month 36
Title
Titers determined if ADAs are identified
Time Frame
From Baseline, Months 4, 8, 12, 16 and Up to Approximately Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria
Signed study companion consent form. A study companion is required for all participants.
HD gene expansion mutation carrier status. CAP score of 400-500, inclusive, where CAP is calculated as follows:
Age x (CAG repeat length -33.66)
-Prodromal HD, defined as DCL 2 to 3, Total Motor Score (TMS) >6, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= 70, and TFC >/=8 (broadly equivalent to HD-ISS Stage 3)
Companion Inclusion Criteria
- HD gene expansion mutation carrier status. CAP score of 400-500, inclusive, where CAP is calculated as follows: Age x (CAG repeat length -33.66)
Prodromal HD, defined as DCL 2 to 3, Total Motor Score (TMS) >6, Independence Scale (IS) = 100 (broadly equivalent to HD-ISS Stage 2), or early manifest HD, defined as DCL 4, TMS > 6, 100 >IS>/= 70, and TFC >/=8 (broadly equivalent to HD-ISS Stage 3)
Signed study companion consent form. A study companion is required for all participants.
Key Exclusion Criteria
Current or previous use of an ASO (including small interfering RNA) or any HTT lowering therapy (including tominersen)
Anti-platelet or anticoagulant therapy within 14 days prior to screening or anticipated use during the study, including, but not limited to, aspirin (unless </= 81 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, apixaban, and heparin
History of gene therapy, cell transplantation, or brain surgery
Hydrocephalus
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of study drug
History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BN42489 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Facility Information:
Facility Name
Uab Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis Medical System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExel Rocky Mountain Clinical Research, LLC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University; Research Division, Psychiatry
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
John Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
CINME
City
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Ramos Mejía
City
Caba
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
INEBA
City
Capital Federal
ZIP/Postal Code
C1192AAX
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1284AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
WESTMEAD HOSPITAL; Deparment of Neurology
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Rigshospitalet, Hukommelsesklinikken
City
Koebenhavn Oe
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU Angers, Batiement Larrey 2, Neurologie
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor; Service de Neurologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Roger Salengro Service de Neurologie
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
CHU toulouse - Hôpital Purpan; Departement de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Uniklinik RWTH Aachen; Klinik für Neurologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
German Center for Neurodegenerative Diseases (DZNE)
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ospedale Bellaria; Istituto delle Scienze Neurologiche
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
New Zealand Brain Research Institute
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Szpital Sw. Wojciecha; Oddzial Neurologiczny
City
Gda?sk
ZIP/Postal Code
80-462
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Santa Maria; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
CNS - Campus Neurológico
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Badajoz; Servicio de Neurología
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Burgos. Servicio de Neurología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Universitätsspital Basel; Neurologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Neurozentrum Siloah
City
Gümligen
ZIP/Postal Code
3073
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
John Radcliffe Hospital; Neurosciences
City
Chinnor
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Chapel Allerton Hospital; Clinical Genetics
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
UCL Hospital NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Southampton University Hospitals NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.
We'll reach out to this number within 24 hrs