At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Viltolarsendrug
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 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls
In Brief
A Phase 2 clinical trial evaluating Viltolarsen for Duchenne Muscular Dystrophy. Completed, enrolled 20 participants across 8 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesChina, Italy, Russia, Spain, Turkey (Türkiye), United States
CollaboratorsNippon Shinyaku Co., Ltd.
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartJul 2021
First PostedJul 2021
Primary CompletionJun 2023
Study CompletionJul 2023
TodayJul 2026
First PostedJul 9, 2021
Enrollment StartJul 1, 2021
Primary CompletionJun 20, 2023
Study CompletionJul 13, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.0 years ago
Interventions
Viltolarsendrug
Received during weekly intravenous infusions