Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT06066580
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Becker Muscular Dystrophy

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sevasemten — DRUG
    Sevasemten is administered orally once per day

Study Details

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

Key Dates

Start date
Nov 2, 2023
Status verified
May 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Drug: Sevasemten

Primary Outcome Measure

Number of adverse events in those treated with sevasemten [ Time Frame: 55 Months ]

Locations (24)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-
UC San DiegoLa JollaCalifornia92037-
UCLA Medical CenterLos AngelesCalifornia90095-
UC Irvine Medical CenterOrangeCalifornia92868-
Stanford Neuroscience Health CenterPalo AltoCalifornia94304-
UC Davis Medical CenterSacramentoCalifornia95817-
UC DenverAuroraColorado80045-
University of FloridaGainesvilleFlorida32611-
Rare Disease ResearchAtlantaGeorgia30329-
Northwestern UniversityChicagoIllinois60611-
Indiana University School of MedicineIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
University of Kansas Medical CenterKansas CityKansas66160-
Kennedy Krieger InstituteBaltimoreMaryland21205-
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01605-
Washington University School of MedicineSt LouisMissouri63110-
University of Rochester Medical CenterRochesterNew York14642-
Rare Disease Research, LLC NCHillsboroughNorth Carolina27278-
University of Cincinnati Gardner Neuroscience InstituteCincinnatiOhio45219-
Nationwide Children's HospitalColumbusOhio43205-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
National Neuromuscular Research InstituteAustinTexas78759-
Neurology Rare Disease CenterDentonTexas76208-
Virginia Commonwealth University HealthRichmondVirginia23298-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARUC San Diego· La Jolla, CAUCLA Medical Center· Los Angeles, CAUC Irvine Medical Center· Orange, CAStanford Neuroscience Health Center· Palo Alto, CAUC Davis Medical Center· Sacramento, CA

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