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.

https://clinicaltrials.gov/ct2/show/NCT01826474?term=pro045&rank=1

   

Verified February 2013 by Prosensa Therapeutics
Sponsor:
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

  

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