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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 is a Phase 2 study that has completed, run by NS Pharma. The registered enrollment target is 20 participants.

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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.

Interventions

  • DRUG Viltolarsen

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-07-01
Est. Completion 2023-07-13
Phase Phase 2

Sponsor

NS Pharma

11 total trials

What the Registry Record Tells You About NCT04956289

The ClinicalTrials.gov registry entry for NCT04956289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NS Pharma, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Viltolarsen is the first listed.

NCT04956289 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.