At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 77 enrolled
Drug / intervention
Viltolarsen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)
In Brief
A Phase 3 clinical trial evaluating Viltolarsen and Placebo for Duchenne Muscular Dystrophy. Completed, enrolled 77 participants across 40 sites in 19 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesAustralia, Canada, Chile, China, Greece, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Norway, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsNippon Shinyaku Co., Ltd.
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartApr 2020
Primary CompletionOct 2023
TodayJul 2026
First PostedAug 19, 2019
Enrollment StartApr 14, 2020
Primary CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.9 years ago
Interventions
Viltolarsendrug
IV infusion
Placebodrug
IV infusion