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