Date: 2011-11-22
Type of
information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Pharnext (France)
Product: PXT-3003 (fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol)
Action
mechanism: PXT-3003 is a fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol.
Disease: Charcot-Marie-Tooth disease
Therapeutic
area: Rare diseases - Genetic diseases - Neurological diseases
Country: France
Trial
details:
- The Phase II clinical trial is a double-blind, placebo-controlled, randomized multicenter study. The patients were randomized between the study’s 4 arms: a placebo arm and 3 arms with the PXT3003 study treatment administered as 3 oral doses twice a day. The study’s objective is to evaluate the pharmacodynamics, pharmacokinetics, safety and efficacy of PXT3003 in CMT1A patients aged 18 to 65 and with genetic confirmation of a duplication on chromosome 17. The results are likely to be published in the first quarter of 2013.
Latest
news:
- • On November 22, 2011, Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments based on Pleotherapy™ for severe, unmet medical needs, announced the on-schedule completion of the recruitment of 80 patients as part of its Phase II study of PXT3003 (the company’s first Pleodrug™) in type 1A Charcot-Marie-Tooth disease1 (CMT1A). \"PXT3003 provides a real prospect of improving the status of patients suffering from CMT1A. Recruitment went according to schedule and none of the enrolled patients have dropped out of the study so far, which is very encouraging\", stated Dr Shahram Attarian (the CLN-PXT3003-01 study’s coordinating investigator at La Timone University Medical Center (Marseilles, France)).
Patient recruitment started in late December 2010 in six investigating centers across France (Lille,Limoges, Lyons, Marseilles, Nantes and Paris) and completed on schedule.
Is
general: Yes
