Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)
About the study
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 the NS-065/NCNP-01-202 study.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Duchenne Muscular Dystrophy
Phase
Phase 4
Participants needed
9
Est. Completion Date
Oct 31, 2032
Treatment type
Interventional
Sponsor
NS Pharma, Inc.
ClinicalTrials.gov identifier
NCT04687020
Study number
VILT-502
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?