An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051
| Status: | Recruiting | 
|---|---|
| Conditions: | Neurology | 
| Therapuetic Areas: | Neurology | 
| Healthy: | No | 
| Age Range: | 12 - Any | 
| Updated: | 1/25/2019 | 
| Start Date: | December 19, 2018 | 
| End Date: | November 1, 2020 | 
| Contact: | Medical information | 
| Email: | clinicaltrials@sarepta.com | 
| Phone: | +1 888 727 3782 | 
The purpose of this extension study is to evaluate the safety, tolerability, and
pharmacokinetics of repeat administrations of SRP-5051 in patients with Duchenne muscular
dystrophy (DMD) who participated in studies of SRP-5051.
			pharmacokinetics of repeat administrations of SRP-5051 in patients with Duchenne muscular
dystrophy (DMD) who participated in studies of SRP-5051.
Inclusion Criteria:
• Has completed Study 5051-101 (NCT03375255) and continues to meet the Safety Eligibility
Criteria of Study 5051-101 (NCT03375255).
Exclusion Criteria:
- Initiation or change of dosing (except for modifications to accommodate changes in
weight) since entering Study 5051-101 (NCT03375255) and while participating in this
study for any of the following: angiotensin converting enzyme (ACE) inhibitors,
angiotensin receptor blocking agents (ARBs), beta-blockers, potassium and steroids*.
- Requires antiarrhythmic and/or diuretic therapy for heart failure.
- Use of any herbal medication/supplement containing aristolochic acid.
- Treatment with any experimental therapy since entering original study or any
experimental gene therapy for the treatment of DMD at any time.
- Participation in an interventional clinical trial since completing original study.
Other inclusion/exclusion criteria apply.
* The dose of steroids must remain constant except for modifications to accommodate changes
in weight.
We found this trial at
    4
    sites
	
								Atlanta, Georgia 30318			
	
			
					Principal Investigator: Han C Phan, MD
			
						
										Phone: 678-883-6897
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									4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
	
			Pittsburgh, Pennsylvania 15224
412-692-5325 
							
					Principal Investigator: Hoda Abdel-Hamid, MD
			
						
										Phone: 412-692-5176
					
		Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...  
  
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								Gulf Breeze, Florida 32561			
	
			
					Principal Investigator: Weldon Mauney, MD
			
						
										Phone: 850-934-1299
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									3901 Rainbow Blvd
Kansas City, Kansas 66160
	
			Kansas City, Kansas 66160
(913) 588-5000 
							
					Principal Investigator: Jeffrey Statland, MD
			
						
										Phone: 913-945-9928
					
		University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...  
  
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