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Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD)

NCT01037309 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-16

Study results available
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Summary

The purpose of this study is to see whether PRO044 is safe and effective to use as medication for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.

Conditions

Interventions

DRUG

PRO044 SC

Subcutaneous injection, once a week, for five weeks

DRUG

PRO044 IV

Intravenous injection, once a week, for five weeks

Sponsors & Collaborators

Principal Investigators

  • A. Ferlini, PhD · Università di Ferrara and S.Anna Hospital, Ferrara, Italy

  • J. J. Verschuuren, MD · Leiden University Medical Center, Leiden, the Netherlands

  • N. Goemans, MD · UZ Leuven, Leuven, Belgium

  • M. Tulinius, MD · The Queen Silvia Children's Hospital, Gothenburg, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-05-31
Completion
2013-10-31
FDA Drug
Yes

Countries

  • Belgium
  • Italy
  • Netherlands
  • Sweden

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 NCT01037309 on ClinicalTrials.gov