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Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy

NCT03907072 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-05-20

Study results available
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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

DRUG

WVE-210201 (suvodirsen)

WVE-210201 is a stereopure antisense oligonucleotide (ASO)

DRUG

Placebo

Buffered saline solution

Sponsors & Collaborators

  • Wave Life Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael A Panzara, MD, MPH · Wave Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2019-12-16
Completion
2020-01-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907072 on ClinicalTrials.gov