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GENERATION HD1

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Sponsored by Roche Pharmaceuticals

Click here for the latest update from Roche. 

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). 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.

 

Status
This study enrollment is not yet recruiting.

Formal Name
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) 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 (RG6042) 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: Not yet recruiting
Coordinator: Joji Decolongon
Phone: 604-822-7928

Alberta
Location: University of Alberta, Edmonton
Status: Not yet recruiting
Coordinator: Paul McCann
Phone: 780-407-1614

Ontario
Location: Centre for Movement Disorders, Toronto
Status: Not yet recruiting

Ontario
Location: Ottawa Hospital, Ottawa
Status: Not yet recruiting

Quebec
Location: Centre Hospitalier de l’Université de Montréal, Montreal
Status: Not yet recruiting
Coordinator: Vicky Thissault
Phone: 514-890-8000 ext. 15921

Nova Scotia
Location: True North Clinical Research, Halifax
Status: Not yet 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 

ClinicalTrials.gov

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.

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