Trials / Terminated
TerminatedNCT03907072
Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy
A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51)
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Wave Life Sciences Ltd. · Industry
- Sex
- Male
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WVE-210201 (suvodirsen) | WVE-210201 is a stereopure antisense oligonucleotide (ASO) |
| DRUG | Placebo | Buffered saline solution |
Timeline
- Start date
- 2019-09-04
- Primary completion
- 2019-12-16
- Completion
- 2020-01-09
- First posted
- 2019-04-08
- Last updated
- 2021-05-20
- Results posted
- 2021-05-20
Locations
22 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Italy, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03907072. Inclusion in this directory is not an endorsement.