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Antisense Oligonucleotide
Long-term Viltolarsen for Duchenne Muscular Dystrophy
Phase 4
Waitlist Available
Research Sponsored by NS Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 120 months of treatment
Awards & highlights
Study Summary
This trial will study the long-term effects of Viltolarsen, given intravenously once a week, in boys with Duchenne Muscular Dystrophy who have completed another study.
Who is the study for?
This trial is for boys with Duchenne Muscular Dystrophy who completed the NS-065/NCNP-01-202 study. They must be able to follow the study plan and have consent from a parent or guardian. Boys with allergies to Viltolarsen, severe behavioral issues, other medical conditions that could affect safety, or those taking investigational drugs post-study are excluded.Check my eligibility
What is being tested?
The trial tests long-term use of Viltolarsen given intravenously once weekly over 10 years in boys with Duchenne Muscular Dystrophy. It's designed to see how they do on this drug after finishing an earlier study (NS-065/NCNP-01-202).See study design
What are the potential side effects?
While specific side effects for Viltolarsen in this context aren't listed here, common ones may include injection site reactions, kidney damage, skin changes, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to up to 120 months of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 120 months of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Performance of Upper Limb (PUL)
Change in Time to Run/Walk 10 meters (TTRW)
Change in Time to Stand (TTSTAND)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Non-interventional (United States) / Low-interventional (Canada) : ViltolarsenExperimental Treatment1 Intervention
Patients will receive viltolarsen (recommended dose 80mg/kg/week) during a treatment period up to 120 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Viltolarsen
2021
Completed Phase 3
~100
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Who is running the clinical trial?
NS Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
565 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I received treatment aimed at increasing dystrophin or related proteins after completing the NS-065/NCNP-01-202 study.
Research Study Groups:
This trial has the following groups:- Group 1: Non-interventional (United States) / Low-interventional (Canada) : Viltolarsen
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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