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Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A

NCT01401257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-22

Study results available
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Summary

The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease.

Conditions

  • Charcot-Marie-Tooth Disease
  • Hereditary Neuropathy With Liability to Pressure Palsies
  • Genetic Disorders

Interventions

DRUG

PXT3003 Low dose

Liquid,5 ml, twice a day, 12-month treatment

DRUG

PXT3003 Intermediate Dose

Liquid,5 ml, twice a day, 12-month treatment

DRUG

PXT3003 High Dose

Liquid,5 ml, twice a day, 12-month treatment

OTHER

Placebo

Liquid,5 ml, twice a day, 12-month treatment

Sponsors & Collaborators

  • Pharnext S.C.A.

    lead OTHER

Principal Investigators

  • Shahram ATTARIAN, MD · Hôpital La Timone

  • Viviane BERTRAND, PhD · Pharnext S.C.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-10-31
Completion
2012-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01401257 on ClinicalTrials.gov