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Sponsored by Roche Pharmaceuticals
GENERATION HD1 was halted on March 22, 2021. For more information please click here.
The GENERATION HD1 study will evaluate the efficacy and safety of RG6042 (now known as tominersen) treatment given once every two months (bi-onthly) or once every four months (16-weeks) over a period of 25 months (approx. two years). Participants will be randomized to one of three treatment study arms: bi-monthly, every four months or placebo bi-monthly. This means for every two participants randomized to tominersen, one will receive placebo. The study is designed to test the potential effects of tominersen compared to placebo. The study is “double-blind” meaning neither the participant nor his/her investigator or site staff will know which study arm the participant is assigned.
Status
Study Closed – Not Recruiting
Formal Name
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (tominersen) in Patients With Manifest Huntington’s Disease
Study Type
Interventional (Clinical Trial)
Purpose
This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (tominersen) compared with placebo in patients with manifest Huntington’s disease (HD).
Canadian Locations and Contact Information:
British Columbia
Location: Centre for HD, UBC Hospital, Vancouver
Status: Suspended/No longer recruiting
Coordinator: Joji Decolongon
Phone: 604-822-7928
Alberta
Location: University of Alberta, Edmonton
Status: No longer recruiting
Coordinator: Paul McCann
Phone: 780-407-1614
Ontario
Location: Centre for Movement Disorders, Toronto
Status: Recruiting
Ontario
Location: Ottawa Hospital, Ottawa
Status: No longer recruiting
Quebec
Location: Centre Hospitalier de l’Université de Montréal, Montreal
Status: No longer recruiting
Coordinator: Vicky Thissault
Phone: 514-890-8000, ext. 15921
Nova Scotia
Location: True North Clinical Research, Halifax
Status: No longer recruiting
Inclusion Criteria
- Aged 25 to 65 years
- 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)
- Any serious medical condition or clinically significant laboratory, or vital sign abnormality 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.