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
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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Atlanta, Georgia 30318
Principal Investigator: Han C Phan, MD
Phone: 678-883-6897
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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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