Status:
TERMINATED
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy
Lead Sponsor:
Processa Pharmaceuticals
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
6-20 years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to test the safety and tolerability of different, increasing doses of an experimental medication called HT-100 in boys and young men with Duchenne muscular dystrophy ...
Eligibility Criteria
Inclusion
- Main
- Ambulatory or non-ambulatory
- Diagnosis of DMD with confirmation of minimal to no dystrophin
- Corticosteroid naive or on therapy for at least 12 months (stable dose and regimen)
- Main
Exclusion
- Recent, substantial change in use of cardiac medications or medications affecting muscle function
- Inability to undergo magnetic resonance imaging (MRI)
- Significantly compromised cardio-respiratory function
- Prior treatment with another investigational product in past 6 months
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2016
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01847573
Start Date
May 1 2013
End Date
March 30 2016
Last Update
September 3 2020
Active Locations (5)
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1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
2
Kennedy Krieger Institute, Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229