clinical trial · NCT04768062
Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)
NS Pharma, Inc.·phase3·unknown·n = 74
Duchenne Muscular DystrophyViltolarsen
brief summary
This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.
started
Apr 13, 2021
primary completion
Oct 1, 2025
completion
Nov 1, 2025
last updated
Feb 14, 2024
detailed description
This Phase 3 study is a multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301. Patients will receive viltolarsen administered IV at weekly doses of 80 mg/kg.
Study NS-065/NCNP-01-302 will be comprised of a 96-week treatment period.
official title
A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol