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An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Patients Who Participated in Prior Roche and Genentech Sponsored Studies

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ClinicalTrials.gov Identifier: NCT03842969
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: RO7234292 (RG6042) Phase 3

Detailed Description:
Entry into the study should occur at the time the participant completes participation in one of the preceding studies. Upon completion of the inclusion visit and any applicable loading dose, eligible patients will receive either RO7234292 (RG6042) every 4 weeks (Q4W) or RO7234292 (RG6042) every 8 weeks (Q8W) by bolus intrathecal injection. Participants who previously received open-label RO7234292 (RG6042) Q4W will receive RO7234292 (RG6042) Q4W in this study; participants who previously received open-label of RO7234292 (RG6042) Q8W will receive RO7234292 (RG6042) Q8W. Participants who did not previously receive treatment with RO7234292 (RG6042) or received short-term treatment with a treatment-free follow-up period will be randomly allocated to receive RO7234292 (RG6042) Q4W or RO7234292 (RG6042) Q8W. If, during the course of the study, a single regimen is selected from the development program, all participants will then be assigned to the selected regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's Disease
Estimated Study Start Date : March 26, 2019
Estimated Primary Completion Date : November 18, 2023
Estimated Study Completion Date : November 18, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RO7234292 (RG6042) Q4W
Participants who previously received open-label RO7234292 (RG6042) every 4 weeks (Q4W) will receive RO7234292(RG6042) Q4W in this study by bolus intrathecal injection. Participants who did not previously receive treatment with RO7234292 (RG6042) or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 (RG6042) Q4W.
Drug: RO7234292 (RG6042)
Intrathecal injection

Experimental: RO7234292 (RG6042) Q8W
Participants who previously received open-label RO7234292 (RG6042) every 8 weeks (Q8W) will receive RO7234292 (RG6042) Q8W in this study by bolus intrathecal injection. Participants who did not previously receive treatment with RO7234292 (RG6042) or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 (RG6042) Q8W (including a loading dose if applicable).
Drug: RO7234292 (RG6042)
Intrathecal injection




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 5 years ]
  2. Change From Baseline in Behavioral Findings, as Assessed by the Columbia-Suicide [ Time Frame: Baseline, Every 4 Weeks or Every 8 Weeks, and End of Treatment (up to approximately 5 years) ]

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior.

    Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety.


  3. Change From Baseline in Cognition, using Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, Every 24 Weeks, End of Treatment (up to approximately 5 years) ]
    MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0−30, where lower scores indicate greater impairment.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior enrollment in a Roche-sponsored or Genentech-sponsored study in HD for the RO7234292 (RG6042) development program that made provision for entry into an OLE study
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
  • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Withdrawal of consent from the preceding study
  • Permanent discontinuation of RO7234292 (RG6042) for any drug-related safety concern during the preceding study or meeting of any study treatment discontinuation criteria specified in the preceding study at the time of enrollment into this study
  • An ongoing, unresolved, clinically significant medical problem that in the judgment of the investigator would make it unsafe for the patient to participate in this study
  • Antiplatelet or anticoagulant therapy within 14 days prior to inclusion or anticipated use during the study, including, but not limited to, aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, and apixaban
  • History of bleeding diathesis or coagulopathy
  • Platelet count less than the lower limit of normal
  • Concurrent participation in any therapeutic clinical trial
  • Study treatment (RO7234292/RG6042) is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842969


Contacts
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Contact: Reference Study ID Number: BN40955 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Canada, British Columbia
University of British Columbia Hospital; Division of Neurology Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Germany
Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie Not yet recruiting
Berlin, Germany, 10117
St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration Not yet recruiting
Bochum, Germany, 44791
Universitätsklinikum Ulm; Klinik für Neurologie Not yet recruiting
Ulm, Germany, 89081
United Kingdom
Birmingham and Solihull Mental Health Foundation Trust; Institute of Clinical Sciences Not yet recruiting
Birmingham, United Kingdom, B15 2TT
Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0SP
University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences Not yet recruiting
Cardiff, United Kingdom, CF14 4XW
University College London Hospitals NHS Foundation Trust - University College Hospital Not yet recruiting
London, United Kingdom, NW1 2PG
Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine Not yet recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03842969     History of Changes
Other Study ID Numbers: BN40955
2018-003898-94 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders