MedTrace Logo

A Study to Assess the Efficacy and Safety of PXT3003 in Charcot-Marie-Tooth Type 1A

NCT05092841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2025-01-09

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled and multicenter 3 phase trial evaluating the therapeutic effect and safety of CMT1A by PXT3003. This double-blind study will assess in parallel groups 1 dose of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.

Conditions

  • Charcot-Marie-Tooth Type 1A

Interventions

DRUG

PXT3003

Patients will be administered PXT3003 twice daily (bid) at 10mL.

DRUG

PXT3003 placebo

Patients will be administered PXT3003 placebo twice daily (bid) at 10mL.

Sponsors & Collaborators

  • Tasly GeneNet Pharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Rui Liu · Tasly Group,Co.Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2024-03-18
Completion
2024-03-18

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092841 on ClinicalTrials.gov