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NCT04956289 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)
A Phase 2 study, sponsored by NS Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04956289: Completed Phase 2 study, sponsored by NS Pharma.
NCT04956289 is a Phase 2 study that has completed, run by NS Pharma. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04956289, a Phase 2 study, has completed, sponsored by NS Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a phase II, open-label study where weekly doses of 80 mg/kg viltolarsen is administered intravenously over a 48-week treatment period to ambulant and non-ambulant DMD patients over the age of 8 years.
Primary Outcome
No statistical analysis was performed for this endpoint. The information has been introduced in the section "Adverse Events".
Interventions
- DRUG Viltolarsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2023-07-13 |
| Phase | Phase 2 |
What the finished NCT04956289 record still lists
NCT04956289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Viltolarsen is the first listed.
NCT04956289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04956289 about?
NCT04956289 is a clinical study titled "Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)". This is a phase II, open-label study where weekly doses of 80 mg/kg viltolarsen is administered intravenously over a 48-week treatment period to ambulant and non-ambulant DMD patients over the age of 8 years.
What is the current status of trial NCT04956289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-07-01. Estimated completion is 2023-07-13.
What interventions are being tested in trial NCT04956289?
The interventions under investigation include: Viltolarsen (DRUG).
Who is sponsoring clinical trial NCT04956289?
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 NCT04956289's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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