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EDG-5506 for Becker Muscular Dystrophy (MESA Trial)

Phase 2
Waitlist Available
Research Sponsored by Edgewise Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 months
Awards & highlights

Summary

This trial looks at how safe and effective a drug is for adults & teens with Becker muscular dystrophy over the long-term.

Who is the study for?
This trial is for adults and adolescents with Becker muscular dystrophy who have completed certain prior studies (EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE) without significant safety concerns. They must not have taken any investigational drugs other than EDG-5506 recently or oral corticosteroids in the past 6 months.
What is being tested?
The study tests the long-term effects of a drug called EDG-5506 on safety, biomarkers, and functional measures in participants with Becker muscular dystrophy. It's an open-label extension meaning everyone knows they are getting the actual drug without any placebo control.
What are the potential side effects?
Specific side effects of EDG-5506 aren't listed here, but generally this phase will monitor for any adverse reactions over a longer period to ensure it's safe when used continuously.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events in those treated with sevasemten
Severity of adverse events in those treated with sevasemten
Secondary outcome measures
Incidence of treatment-emergent abnormal clinical chemistry laboratory test results
Incidence of treatment-emergent abnormal hematology laboratory test results

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Drug: Sevasemten
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevasemten
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,260 Total Patients Enrolled
Edgewise Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
666 Total Patients Enrolled
Roxana D. Dreghici, MDStudy ChairEdgewise Therapeutics, Inc.
~133 spots leftby Mar 2028
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