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Sponsored by Roche Pharmaceuticals
GEN-EXTEND was paused on March 22, 2021. For more information please click here.
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, eligible participants will receive either RO7234292 (RG6042) every 8 weeks (Q8W) or RO7234292 (RG6042) every 16 weeks (Q16W) by bolus intrathecal injection.
Status
Study Paused – Not Recruiting
Formal Name
An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington’s Disease
Study Type
Interventional (Clinical Trial)
Purpose
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.
Canadian Locations:
British Columbia
Location: University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada, V6T 2B5
Status: Recruiting
Ontario
Location: Centre for Movement Disorders
North York, Ontario, Canada, M3B 2S7
Status: Recruiting
Ontario
Location: Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Status: Recruiting
Quebec
Location: Centre Hospitalier de l’Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C2
Status: Recruiting
Ages Eligible for Study: 25 Years and older (Adult, Order Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
- Patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic
Inclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic:
- 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 (eligibility that would exclude you from this study)
- 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
Exclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relation to the COVID-19 pandemic:
- 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
Source
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.