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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 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 120 months of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to 120 months of treatment for reporting.

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 more

Trial 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

Find a Location

Who is running the clinical trial?

NS Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
565 Total Patients Enrolled

Media Library

Viltolarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04687020 — Phase 4
Duchenne Muscular Dystrophy Research Study Groups: Non-interventional (United States) / Low-interventional (Canada) : Viltolarsen
Duchenne Muscular Dystrophy Clinical Trial 2023: Viltolarsen Highlights & Side Effects. Trial Name: NCT04687020 — Phase 4
Viltolarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04687020 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic expanse is this clinical experiment being administered?

"This clinical trial is being administered out of Duke University Medical Centre in Durham, North carolina, Lurie Children's Hospital in Chicago, Illinois and the Children's Hospital of Richmond at VCU in Virginia. There are also 5 other sites involved with this study."

Answered by AI

What is the maximum number of participants for this clinical trial?

"At the present moment, this clinical trial is not enrolling patients. It was initially posted on June 10th 2021 and last modified on October 18 2022. If you are seeking other studies related to muscular dystrophy, there are 86 active trials in progress and 4 dedicated to the subject of interest that require participants right now."

Answered by AI

Has this research been conducted previously?

"To date, there are 4 ongoing clinical trials of this drug being conducted in 8 cities and 20 countries. The inaugural study began in 2020 with NS Pharma, Inc. as the primary sponsor and included 74 participants who completed Phase 3 testing. Subsequently, an additional three studies have been launched since then."

Answered by AI

Are there any documented experiments that have utilized this therapeutic approach?

"Currently, 4 clinical studies are exploring this treatment; two of which are in the terminal phase. Most trials for this particular medication take place in Rome, Oregon but additional testing sites can be found at 70 different locations across the globe."

Answered by AI

Has this intervention been approved by the Federal Drug Administration?

"As this is a Phase 4 trial, signifying that the treatment has already been approved for use, we have considered it to be of high safety and assigned a rating score of 3."

Answered by AI

Are there currently any available openings for this research endeavor?

"This research is not recruiting at the moment. Initially posted on June 10th 2021 and most recently updated in October 18th 2022, it cannot accept any new patients. If you are seeking alternative studies, there are 86 trials for muscular dystrophies and 4 investigations looking for subjects to trial this medication available now."

Answered by AI

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Alberta Children's Hospital
How many prior treatments have patients received?
1

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Alberta Children's Hospital: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)
2021. "Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04687020.
All > Muscular Dystrophy
~6 spots leftby Sep 2032
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