EDG-5506 for Duchenne Muscular Dystrophy
(LYNX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests EDG-5506, a pill taken regularly, in children aged 4 to 9 with Duchenne muscular dystrophy. It aims to see if the medication is safe and can reduce muscle damage. The study includes both children who are and are not currently on corticosteroids.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop all current medications. However, if you are in Cohort 2 Non-Steroid, you should not have taken corticosteroids in the 6 months before the trial. Participants in other cohorts must be on a stable dose of corticosteroids for at least 6 months before the trial.
Will I have to stop taking my current medications?
If you are in Cohort 2 Non-Steroid, you should not have taken corticosteroids in the past 6 months. For other cohorts, you need to be on a stable dose of corticosteroids for at least 6 months before starting the trial.
What safety data is available for EDG-5506 in treating Duchenne Muscular Dystrophy?
The provided research does not contain any safety data specific to EDG-5506 or its alternative names like Sevasemten, EDG-5506 Dose 1, Dose 2, Dose 3, Placebo, Control, or Dummy Treatment. The studies focus on different compounds such as ethylenediamine, hexamethylenediamine, stearamidoethyl diethylamine, didecyldimethylammonium bromide, and trisodium ethylenediaminetetraacetate, none of which are related to EDG-5506. Therefore, no relevant safety data for EDG-5506 is available in the provided research.12345
Is the drug EDG-5506 a promising treatment for Duchenne Muscular Dystrophy?
What data supports the idea that the drug EDG-5506 for Duchenne Muscular Dystrophy is an effective treatment?
The available research does not provide any data on the effectiveness of EDG-5506 for Duchenne Muscular Dystrophy. The studies mentioned focus on other drugs and treatments for different conditions, such as cancer and chemotherapy-induced nausea, and do not include information on EDG-5506.1112131415
Who Is on the Research Team?
Sam Collins, MBBS, PhD
Principal Investigator
Edgewise Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for children with Duchenne muscular dystrophy who have a specific DMD gene mutation. They must be able to stand and climb stairs quickly, weigh between 15-35 kg, and either be aged 4-9 years on stable corticosteroids or aged 4-7 not on steroids recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Randomized, double-blind, placebo-controlled treatment period
Open-label Extension Part B
Participants receive open-label sevasemten treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EDG-5506 Dose 1
- EDG-5506 Dose 2
- EDG-5506 Dose 3
- Placebo
EDG-5506 Dose 1 is already approved in United States for the following indications:
- No approvals yet; has received Fast Track designation for Duchenne muscular dystrophy and Becker muscular dystrophy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edgewise Therapeutics, Inc.
Lead Sponsor