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A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy

NCT03400852 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-03-16

Study results available
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Summary

This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).

Conditions

  • Muscular Dystrophy, Duchenne

Interventions

DRUG

MNK-1411

MNK-1411 (1 mg/mL suspension) for subcutaneous injection

OTHER

Placebo

Placebo suspension for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt ARD LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Study Lead · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2020-02-25
Completion
2020-02-25
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Israel
  • Italy
  • Mexico
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

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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 NCT03400852 on ClinicalTrials.gov