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Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension

NCT04004000 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-02

Study results available
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Summary

This clinical trial is a study to evaluate the safety, tolerability, and changes in biomarker and clinical outcome assessments of Losmapimod for patients with Facioscapulohumeral Muscular Dystrophy 1 (FSHD1) with an open-label extension.

Conditions

  • Facioscapulohumeral Muscular Dystrophy 1

Interventions

DRUG

Losmapimod

The main study includes a treatment period of approximately one year. Subjects will receive 15 mg of losmapimod twice daily by mouth; for a total of 30 mg daily. The study drug should be taken with food and the date and time of each dose taken recorded in the subject diary. Only subjects who participated in and completed all procedures for the main study (Week 60) will be eligible to participate in the extension. For the extension, subjects will receive 15 mg of losmapimod by mouth twice daily for a total of 30 mg by mouth daily. Participation will continue until 90 days after commercial drug is available post regulatory approval or study termination.

Sponsors & Collaborators

  • Fulcrum Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Netherlands

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 NCT04004000 on ClinicalTrials.gov