Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study

Publication date: Available online 15 December 2018Source: The Lancet NeurologyAuthor(s): Ralf Reilmann, Andrew McGarry, Igor D Grachev, Juha-Matti Savola, Beth Borowsky, Eli Eyal, Nicholas Gross, Douglas Langbehn, Robin Schubert, Anna Teige Wickenberg, Spyros Papapetropoulos, Michael Hayden, Ferdinando Squitieri, Karl Kieburtz, G Bernhard Landwehrmeyer, European Huntington's Disease Network, Pinky Agarwal, Karen E Anderson, Nasir A Aziz, Jean-Phillippe Azulay, Anne C Bachoud-LeviSummaryBackgroundPrevious trials have shown that pridopidine might reduce motor impairment in patients with Huntington's disease. The aim of this study was to ascertain whether higher doses of pridopidine than previously tested reduce motor symptoms in a dose-dependent manner while maintaining acceptable safety and tolerability.MethodsPRIDE-HD was a randomised, placebo-controlled, phase 2, dose-ranging study in adults (aged ≥21 years) with Huntington's disease at outpatient clinics in 53 sites across 12 countries (Australia, Austria, Canada, Denmark, France, Germany, Italy, Poland, Russia, the Netherlands, the UK, and the USA). Eligible patients had clinical onset after age 18 years, 36 or more cytosine-adenine-guanine repeats in the huntingtin gene, motor symptoms (Unified Huntington's Disease Rating Scale total motor score [UHDRS-TMS] ≥25 points), and reduced independence (UHDRS independence score ≤90%). Patients were randomly assigned (1:1:1:1:1) with centralised interactive-response technol...
Source: The Lancet Neurology - Category: Neurology Source Type: research