Status:
ACTIVE_NOT_RECRUITING
Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)
Lead Sponsor:
NS Pharma, Inc.
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
The VILT-502 study is Non-interventional Study(United States)/Low-intervention Clinical Trial (Canada) of Viltolarsen administered intravenously once weekly for 10 years to boys with DMD who complete ...
Detailed Description
The VILT-502 study is an open-label, single-arm study to assess the long-term safety and effectiveness of viltolarsen, an exon skipping therapy for the treatment of DMD. Patients who complete the Phas...
Eligibility Criteria
Inclusion
- Patient, patient's parent or legal guardian have provided written informed consent/medical record release authorization prior to any extension study-specific procedures, and the patient has provided assent appropriate for his age and developmental status.
- Patient completed the NS-065/NCNP-01-202 study and was judged by the investigator as appropriate to participate in the VILT-502 study.
- Patient and parent or legal guardian are willing and able to comply with scheduled visits, study treatment administration plan, and study procedures.
Exclusion
- Patient has an allergy or hypersensitivity to the study drug or to any of its constituents.
- Patient has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.
- Patient has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and observation will be correctly completed or impair the assessment of study results, in the opinion of the investigator.
- Patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completing the NS-065/NCNP-01-202 study.
- Patient took any other investigational drugs after completing the NS-065/NCNP-01-202 study.
- Patient plans to participate in another clinical trial.
- Patient was judged by the investigator and/or the Sponsor as not appropriate to participate in the study for reasons other than #1 - #6 above.
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2032
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04687020
Start Date
June 10 2021
End Date
October 1 2032
Last Update
October 19 2022
Active Locations (5)
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1
UC Davis
Sacramento, California, United States, 95817
2
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23230