HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol(DIM20)V1
Research type
Research Study
Full title
HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease
IRAS ID
45713
Contact name
Hugh Rickards
Sponsor organisation
Medivation, Inc.
Eudract number
2009-018123-32
Research summary
This study is an open-label extension study of oral dimebon (20 mg three times per day [TID]), administered to subjects with Huntington's Disease (HD) who have successfully completed 26 weeks of blinded treatment in the HORIZON study (DIM20). Up to 350 subjects (the randomization part for HORIZON) will be offered participation in this extension study. All subjects will receive dimebon 10 mg TID for the first seven days of therapy, before escalating to dimebon 20 mg TID until commercially available in their respective countries, or until study termination at the discretion of the Sponsor or if recommended by the HORIZON Data Monitoring Committee (DMC). Patients, Site Investigators, and the members of the Sponsor??s staff overseeing the conduct of the study will remain blinded to the original treatment assignment in the HORIZON study upon enrollment into HORIZON-Plus.
REC name
Scotland A REC
REC reference
10/MRE00/25
Date of REC Opinion
14 May 2010
REC opinion
Further Information Favourable Opinion