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Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy
Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy
This study is currently recruiting participants.
http://clinicaltrials.gov/ct2/show/NCT01826474?term=pro045&rank=1
Verified February 2013 by Prosensa Therapeutics
Sponsor:
Prosensa Therapeutics
Information provided by (Responsible Party):
Prosensa Therapeutics
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.
| Condition | Intervention | Phase |
|---|---|---|
| Duchenne Muscular Dystrophy | Drug: PRO045, 0.15 mg/kg/week Drug: PRO045, 1.0 mg/kg/week Drug: PRO045, 3.0 mg/kg/week Drug: PRO045, 6.0 mg/kg/week Drug: PRO045, 9.0 mg/kg/week Drug: PRO045, selected dose |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Open-label Study to Assess the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Multiple Subcutaneous Doses of PRO045 in Subjects With Duchenne Muscular Dystrophy |
