Expected Study Locations Announced for Pivotal Huntington Disease Clinical Trial
(KITCHENER, ON) DECEMBER 19, 2018 – Roche Pharmaceuticals announced today the expected locations of the clinical trial sites in Canada that will be participating in the Phase III GENERATION HD1 study. The locations that are anticipated to participate are:
- Edmonton, Alberta - University of Alberta
- Vancouver, British Columbia - University of British Columbia
- Ottawa, Ontario - Ottawa Hospital
- Toronto, Ontario - Centre for Movement Disorders
- Halifax, Nova Scotia - Queen Elizabeth II Health Sciences Centre
- Montreal, Quebec - Centre Hospitalier de l’Université de Montréal
This announcement comes just one year after the phase Ia/IIb trial showed that the drug successfully lowered the harmful huntingtin protein in spinal fluid that causes Huntington disease (HD) and was deemed initially safe and well tolerated.
The GENERATION HD1 study will evaluate the efficacy and safety of RG6042 treatment given once per month or once every two months (bi-monthly) over a period of 25 months (approx. two years). This global study will enrol up to 660 patients with manifest HD at 80-90 sites in approximately 15 countries around the world. The study will start to enrol by early 2019.
Participants of the study will be randomized to one of three treatment study arms: monthly, bi-monthly or placebo monthly. This means for every two participants randomized to RG6042, one will receive placebo. The study is designed to test the potential effects of RG6042 compared to placebo. The study is “double-blind” so neither the participant nor investigator or site staff will know which study arm the participant is assigned.
“This is a hopeful time for the HD community and this announcement is another positive step forward,” says Robin Markowitz, HSC’s CEO. “Roche’s decision to run clinical trials in Canada speaks to the calibre of our doctors and scientists, who are leading the way in HD research. It also speaks to the level of engagement within the Canadian HD community. I applaud the volunteers who have stepped up and who will continue to step up for research. Their bravery pushes us closer than ever towards meaningful treatments.”
If families have specific questions about participating in clinical trials we recommend they contact their local Movement Disorders or Huntington disease clinic. We will also continue to update the HSC website with the most current information at www.huntingtonsociety.ca/roche-rg6042-update.
Huntington disease (HD) is a debilitating brain disorder that is fatal and incurable. About one in every 7,000 Canadians has HD and approximately one in every 5,500 is at-risk of developing the disease. Many more are touched by HD whether as a caregiver, a family member, or a friend. HD causes cells in specific parts of the brain to die. As the disease progresses, a person with Huntington disease becomes less able to manage movements, recall events, make decisions and control emotions. Many describe the symptoms of HD as having ALS, Parkinson’s and Alzheimer’s – simultaneously.
The Huntington Society of Canada (HSC) is a respected leader in the worldwide effort to end Huntington disease. HSC is the only Canadian health charity dedicated to providing help and hope for families dealing with Huntington disease across Canada.