GENERATION HD1
A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON’S DISEASE
Active, not recruiting
ABOUT
SPONSOR
Hoffmann-La Roche
PARTICIPANTS
909
Generation HD1 is a Phase III trial where Huntington’s disease patients get injections in the spine with a drug called Tominersen (previously called RG6042). The drug is aiming to lower the amount of Huntingtin protein in brain cells. Some of the participants get the active drug injected every 2nd months, another group gets the active drug every 4 months and a third group gets injected with a placebo drug. The potential effect of the study will be measured by testing cognitive, motor and social functioning.
Estimated Study Completion Date: 9 July, 2022
COUNTRIES
UPDATES
The Roche GENERATION-HD1 global phase 3 trial of tominersen (RG6042), an antisense oligonucleotide, completed enrollment in 2020, with 791 participants enrolled across approximately 100 sites in 18 countries.
Study treatment and follow-up assessments are ongoing, and on completion, participants are offered the opportunity to enroll in the open-label extension (OLE) study, GEN-EXTEND.