14 October 2019
Update on the Phase III GENERATION HD1 study
Dear global HD patient community,
Today we are pleased to announce that we are increasing the total enrolment in the GENERATION HD1 study (NCT03761849) from 660 to 801 participants worldwide. We believe that increasing enrolment now – before study recruitment closes – keeps the study on track to complete within expected timelines. This study change does not impact participants already enrolled in the study, but it allows for additional patients to enrol in each of the three
The GENERATION HD1 study is evaluating the efficacy and safety of the investigational molecule RG6042 in people with manifest HD. The 25-month study is testing two dosing regimens compared to placebo – RG6042 once every two months (eight weeks) or RG6042 every four months (16 weeks). The open-label extension of the Phase I/IIa study is ongoing and supports the exploration of the two dosing groups in the GENERATION HD1 study.