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RG6042 Huntingtin-Lowering Trial Information

November 2018 Observational Huntington disease Natural History Study Update:

On November 7, 2018, Roche Pharmaceuticals announced the locations of the clinical trial sites in Canada that will be participating in the Observational Huntington disease Natural History Study.

The locations of the Canadian sites participating in the Natural History Study are:

  • Vancouver, British Columbia – University of British Columbia Centre for Huntington disease
  • Toronto, Ontario – Centre for Movement Disorders

These sites are not fully active yet, but Roche hopes to complete the final steps as quickly as possible.  For our families, if you have specific questions about participating in clinical trials we recommend that you contact your local Movement Disorders or Huntington disease clinic.  We will also continue to update the HSC website with the most current information.  You can find that information here.

Below is the information regarding the Observational HD Natural History Study:

  • This 15-month observational study aims to further understand the role of mutant huntingtin in disease progression.
  • There is no drug treatment in this study, as the goal is to understand the natural progression of HD.
  • This study will include up to 100 participants globally with early manifest (Stage I and II) HD at up to 17 sites
  • The sites include Canada, Germany, the United Kingdom and the United States.
  • This study is expected to start enrollment shortly

In addition to the Observational Huntington disease Natural History Study, Roche Pharmaceuticals is also working on the set-up of a second clinical trial that they hope to launch by the end of 2018 or early 2019.

Below is the information for Roche’s second Huntington disease clinical trial.

Upcoming Phase III Generation HD1 study:

  • This global study will enroll up to 660 patients with manifest HD at 80-90 sites in approximately 15 countries around the world. The study is expected to begin at the end of 2018 with patients starting to enroll by early 2019.
  • Participants 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” meaning neither the participant nor his/her investigator or site staff will know which study arm the participant is assigned.

At the 2018 HSC National Conference last week, Dr. Blair Leavitt from UBC and Dr. Lauren Boak from Roche, provided an update on Huntingtin-Lowering therapies and Roche’s Huntington disease program.  You can view that update on the HSC Facebook page here.

This is a hopeful time for the Huntington disease community and this announcement is another positive step forward.  We will continue to update you as more information becomes available.

Sincerely,

Robin Markowitz

CEO, Huntington Society of Canada


For the full history of updates on this trial, click here.


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