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EDG-5506 for Duchenne Muscular Dystrophy (LYNX Trial)

Q: Does this research involve volunteers who are below the age of twenty?

This trial seeks patients ranging from 4 to 9 years old.

Q: How safe is Cohort 2 for human participants?

The safety of Cohort 2 scored a 2 on our scale, as there is evidence that it is safe to use but no data yet demonstrating its efficacy.

Q: Are there any open positions available to participants in this investigation?

The public records on clinicaltrials.gov confirm that this particular medical trial is actively seeking participants, with the first posting having been made on October 1st 2022 and its most recent update occurring in late-October of the same year.

Q: What goals is this trial aiming to accomplish?

The main aim of the trial, which will be monitored over 12 months, is to assess severity of any adverse events resulting from EDG-5506 and placebo. Additionally, secondary objectives for this experiment include observing changes in neurological examinations among <a href="https://www.withpower.com/clinical-trials/all">all</a> participants as well as alterations in fast skeletal muscle troponin I levels and coagulation records across all patients.

Q: Which individuals would be ideal candidates for this clinical trial?

To qualify for this trial, participants must meet the criteria of having <a href="https://www.withpower.com/clinical-trials/muscular-dystrophy">muscular dystrophy</a> (Duchenne) and should be between 4 to 9 years old. The study is currently searching for 27 enrollees.

Q: What is the upper limit of participants in this medical research study?

Indeed, the official data posted on clinicaltrials.gov attests to this experiment's active recruitment process. It was first listed on October 1st 2022 and recently updated on October 24th of the same year. The trial aims to enrol 27 patients from a single site.

Phase 2

Recruiting

Research Sponsored by Edgewise Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to complete the stand from supine in ≤ 10 seconds and able to perform the 4-stair climb in < 10 seconds at the Screening visit

Body weight greater than or equal to 15 kg and less than 35 kg at the Screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

LYNX Trial Summary

This trial is studying safety, how a drug is absorbed and how it affects biomarkers in kids with Duchenne muscular dystrophy. It will be done in two parts.

Who is the study for?

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.Check my eligibility

What is being tested?

The LYNX study tests different doses of EDG-5506 against a placebo in two parts: one where neither the researchers nor participants know who's getting what (double-blind), followed by an open-label part where everyone knows which treatment is given.See study design

What are the potential side effects?

While specific side effects are not listed here, they will monitor safety closely. This could include checking how the body processes the drug (pharmacokinetics) and changes in certain health markers.

LYNX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can stand up from lying down in less than 10 seconds and climb four stairs in less than 10 seconds.

Select...

My weight is between 15 kg and 35 kg.

Select...

I have a confirmed genetic mutation for Duchenne muscular dystrophy.

LYNX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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 during treatment with EDG-5506 or placebo

Severity of adverse events during treatment with EDG-5506 or placebo

Secondary outcome measures

Change from Baseline in fast skeletal muscle troponin I

Change from Baseline in serum creatinine kinase

Incidence of abnormal clinical chemistry test results

+4 more

LYNX Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Group II: Cohort 4Experimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Group III: Cohort 3Experimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Group IV: Cohort 2NSExperimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Group V: Cohort 2Experimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Group VI: Cohort 1Experimental Treatment2 Interventions

Drug: EDG-5506 Drug: Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edgewise Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

812 Total Patients Enrolled

Sam Collins, MBBS, PhDStudy ChairEdgewise Therapeutics, Inc.

6 Previous Clinical Trials

431 Total Patients Enrolled

Media Library

EDG-5506 Dose 1 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05540860 — Phase 2

Duchenne Muscular Dystrophy Research Study Groups: Cohort 3, Cohort 4, Cohort 5, Cohort 2NS, Cohort 2, Cohort 1

Duchenne Muscular Dystrophy Clinical Trial 2023: EDG-5506 Dose 1 Highlights & Side Effects. Trial Name: NCT05540860 — Phase 2

EDG-5506 Dose 1 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540860 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve volunteers who are below the age of twenty?

"This trial seeks patients ranging from 4 to 9 years old."

Answered by AI

How safe is Cohort 2 for human participants?

"The safety of Cohort 2 scored a 2 on our scale, as there is evidence that it is safe to use but no data yet demonstrating its efficacy."

Answered by AI

Are there any open positions available to participants in this investigation?

"The public records on clinicaltrials.gov confirm that this particular medical trial is actively seeking participants, with the first posting having been made on October 1st 2022 and its most recent update occurring in late-October of the same year."

Answered by AI

What goals is this trial aiming to accomplish?

"The main aim of the trial, which will be monitored over 12 months, is to assess severity of any adverse events resulting from EDG-5506 and placebo. Additionally, secondary objectives for this experiment include observing changes in neurological examinations among all participants as well as alterations in fast skeletal muscle troponin I levels and coagulation records across all patients."

Answered by AI

Which individuals would be ideal candidates for this clinical trial?

"To qualify for this trial, participants must meet the criteria of having muscular dystrophy (Duchenne) and should be between 4 to 9 years old. The study is currently searching for 27 enrollees."

Answered by AI

What is the upper limit of participants in this medical research study?

"Indeed, the official data posted on clinicaltrials.gov attests to this experiment's active recruitment process. It was first listed on October 1st 2022 and recently updated on October 24th of the same year. The trial aims to enrol 27 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)

2022. "A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540860.

All > Muscular Dystrophy