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Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy

NCT01826474 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-08

No results posted yet for this study

Summary

The purpose of the study is to see whether PRO045 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA for the dystrophin protein.

Conditions

Interventions

DRUG

PRO045, 0.15 mg/kg/week

Subcutaneous injection

DRUG

PRO045, 1.0 mg/kg/week

Subcutaneous injection

DRUG

PRO045, 3.0 mg/kg/week

Subcutaneous injection

DRUG

PRO045, 6.0 mg/kg/week

Subcutaneous injection

DRUG

PRO045, 9.0 mg/kg/week

Subcutaneous injection

DRUG

PRO045, selected dose

Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • T. Voit, MD PhD · Institut de Myologie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Belgium
  • France
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01826474 on ClinicalTrials.gov