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NCT04060199 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)
A Phase 3 study, sponsored by NS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT04060199: Completed Phase 3 study, sponsored by NS Pharma.
NCT04060199 is a Phase 3 study that has completed, run by NS Pharma. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04060199, a Phase 3 study, has completed, sponsored by NS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
Primary Outcome
The change from baseline for velocity converted from TTSTAND was compared between the viltolarsen-treated patients and the placebo-treated patients. TTSTAND was assessed as the time it takes the participant to go from lying flat on the floor to standing. The time measured for TTSTAND was converted to a velocity expressed as rise per second.
Interventions
- DRUG Placebo
- DRUG Viltolarsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-04-14 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 3 |
What the finished NCT04060199 record still lists
NCT04060199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04060199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04060199 about?
NCT04060199 is a clinical study titled "Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)". The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
What is the current status of trial NCT04060199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2020-04-14. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT04060199?
The interventions under investigation include: Placebo (DRUG), Viltolarsen (DRUG).
Who is sponsoring clinical trial NCT04060199?
This trial is sponsored by NS Pharma, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04060199's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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