CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 323 enrolled
Drug / intervention
PXT3003 dose 1 +2 moredrug
Likely dose
PXT3003 dose 1 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02579759
NCT02579759Phase 3Completed

International, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study Assessing in Parallel Groups the Efficacy and Safety of 2 Doses of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A Treated 15 Months

Pharnext S.C.A.·interventional·Posted Oct 20, 2015·Updated Feb 27, 2020

In Brief

A Phase 3 clinical trial evaluating PXT3003 dose 1, PXT3003 dose 2, and 1 other intervention for Charcot-Marie-Tooth Disease Type 1A. Completed, enrolled 323 participants across 30 sites in 8 countries.

Detailed Summary

The purpose of this study is to determine whether PXT3003 is effective and safe in the treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, France, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartDec 1, 2015
Primary CompletionMar 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.7 years ago

Interventions

PXT3003 dose 1drug

Liquid oral solution, 5 ml twice a day, morning and evening with food

PXT3003 dose 2drug

Liquid oral solution, 5 ml twice a day, morning and evening with food

placebodrug

Liquid oral solution, 5 ml twice a day, morning and evening with food