As reported in April 24, 2014 Teva’s official note, “The Pride-HD Study, is a phase II, dose-finding, randomized, parallel-group, double-blind, placebo-controlled study, that aims to enroll approximately 400 patients at 30 sites across the globe and evaluate the safety and efficacy of pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg twice daily (bid) versus placebo for symptomatic treatment in patients with HD. The primary objective will be to assess the efficacy of pridopidine on motor impairment after 26 weeks of treatment using the Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score (TMS). The study will also examine the effect of treatment with pridopidine on the Physical Performance Test (PPT), as well as the safety and tolerability across the range of pridopidine doses in patients with HD during the 26 weeks of treatment.
Pridopidine is an investigational, oral, small molecule being developed for the symptomatic treatment of Huntington’s disease (HD). Teva intends to design and complete new clinical studies of pridopidine to assess its potential for symptomatic relief of HD. Earlier clinical studies of pridopidine conducted in the U.S., EU and Canada in patients with HD indicate a significant treatment effect on an important secondary endpoint, Total Motor Score (TMS).”
There is a motivated hope related to this trial’s results, from both patients and scientific community, because two previous pridopidine trials indicated the promising potental of this drug for symptomatic treatment of HD.
“We believe Pridopidine may perhaps have the potential to even change some aspects of HD clinical history”, says Ferdinando Squitieri, head of the Centre for Neurogenetics and Rare Diseases at IRCCS Neuromed and President of the Italian League for Research on Huntington and related diseases (LIRH). Fedinando Squitieri is the Principal Investigator of the leading Centre in Italy. The drug trial is coordinated in Europe by Dr Ralf Reilmann, funder of Gearge Huntington Institute in Muenster, Germany.
Dr. Squitieri has already been coordinating Italian teams in the previous international pridopidine trial, by contributing with the highest number of patients recruited in the world. Squitieri’s team is aware of the complexity of such important pharmachological trial that, for the first time in Italy, requests the use of the Q-Motor assay (which is a new objective investigator-independent instrument to score motor impairment of Huntington disease set by Dr Reilmann, Germany).
The Italian patient’s community from LIRH is close to researchers and looks forward to wellcoming good news.