Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Hope for becker MD: new drug shows promise in Long-Term trial

NCT ID NCT06066580

Disease control Sponsor: Edgewise Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study looks at the long-term safety and effects of a drug called EDG-5506 (sevasemten) in people with Becker muscular dystrophy, a muscle-weakening disease. About 260 adults and teens who were in earlier EDG-5506 studies will take the drug and be monitored for side effects and changes in muscle health. The goal is to see if the drug remains safe and helpful over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1\. Males with a diagnosis of BMD and participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows: * EDG-5506-002 ARCH: Complete the final study Visit 27 \[Month 24\]; or, completion of the ET visit prior to Visit 27 \[Month 24\] * EDG-5506-201 CANYON and GRAND CANYON: Complete the final study visit (Cohorts 1, 2, 4, and 5: Visit 12 \[Month 12\]; Cohort 6: Visit 11 \[Month 18\]) * EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment (Visit 14 \[Week 52\]) Key Exclusion Criteria: 1. Any clinically significant changes during or following participation in EDG-5506-002, EDG-5506-201, or EDG-5506-202 that would affect the potential safety of the participant to receive sevasemten. 2. Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers. 3. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study. 4. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Becker muscular dystrophy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Becker muscular dystrophy Duchenne muscular dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Becker muscular dystrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Hopital Pitie-Salpetriere

    Paris, France, 75013, France

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Azienda Ospedale - Università Padova

    Padova, Italy, 35128, Italy

  • CHU de Nantes

    Nantes, France, 44093, France

  • CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires

    Nice, France, 06001, France

  • Centre Hospitalier Régional de la Citadelle

    Liége, Belgium, 4000, Belgium

  • Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone

    Marseille, France, 13005, France

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore

    Milan, Italy, 20122, Italy

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome, Italy, 00168, Italy

  • Hadassah University Hospital

    Jerusalem, 91240, Israel

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain, 46026, Spain

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Spain, 20014, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain, 08035, Spain

  • Hospital Universitario de Bellvitge

    Barcelona, Spain, 08907, Spain

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    Munich, Germany, 80336, Germany

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • National Neuromuscular Research Institute

    Austin, Texas, 78759, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Neurology Rare Disease Center

    Denton, Texas, 76208, United States

  • Newcastle Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Optimal Clinical Trials

    Auckland, 1023, New Zealand

  • Rare Disease Research

    Atlanta, Georgia, 30329, United States

  • Rare Disease Research, LLC NC

    Hillsborough, North Carolina, 27278, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Salford Royal Hospital

    Salford, United Kingdom, M68HD, United Kingdom

  • St Vincent's Hospital

    Melbourne, Victoria, 3065, Australia

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • Stanford Neuroscience Health Center

    Palo Alto, California, 94304, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UC Denver

    Aurora, Colorado, 80045, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UC San Diego

    La Jolla, California, 92037, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Universitaire Ziekenhuizen Leuven

    Leuven, Belgium, 3000, Belgium

  • University College London Hospital

    London, NW1 2PG, United Kingdom

  • University Hospital Gent

    Ghent, Belgium, 9000, Belgium

  • University of Cincinnati Gardner Neuroscience Institute

    Cincinnati, Ohio, 45219, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01605, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.