PRidopidine Outcome On Function in Huntington Disease (PROOF-HD)

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease

• IRAS ID

  289461

• Contact name

  Anne Rosser

• Contact email

  RosserAE@cardiff.ac.uk

• Sponsor organisation

  Prilenia Neurotherapeutics Ltd.

• Eudract number

  2020-002822-10

• Clinicaltrials.gov Identifier

  NCT04556656

• Clinicaltrials.gov Identifier

  77419, IND

• Duration of Study in the UK

  2 years, 3 months, 31 days

• Research summary

  The purpose of this research study is to evaluate the safety and effectiveness of the study drug, pridopidine, on everyday functioning and daily activities, as well as movement and behaviour in participants with early stage Huntington Disease. The study will last at least 65 weeks with a variable extension of up to additional 13 weeks.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  20/LO/1270

• Date of REC Opinion

  21 Jan 2021

• REC opinion

  Further Information Favourable Opinion