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Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT04003974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-10

Study results available
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Summary

This is a study to evaluate the safety and efficacy of Losmapimod in treating patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.

Conditions

  • Facioscapulohumeral Muscular Dystrophy (FSHD)

Interventions

DRUG

Losmapimod oral tablet

Losmapimod will be administered with food when possible.

DRUG

Placebo oral tablet

Placebo will be administered with food when possible

Sponsors & Collaborators

  • Fulcrum Therapeutics

    lead INDUSTRY

Principal Investigators

  • Michelle Mellion, MD · Fulcrum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-01-28
Completion
2021-01-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Spain

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 NCT04003974 on ClinicalTrials.gov