Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty
Trial Summary
What is the purpose of this trial?
This trial tests MYMD1, a drug aimed at reducing inflammation, in older adults with muscle weakness and frailty. The drug works by lowering the chemicals that cause inflammation, potentially improving muscle strength.
Will I have to stop taking my current medications?
The trial requires that you stop taking anti-inflammatory drugs on a daily basis. If you are on a stable antidepressant regimen for at least 3 months and agree not to increase the dose during the trial, you may continue taking it. Other medications, especially those with narrow therapeutic ranges, systemic steroids, and certain other drugs, may also need to be stopped or adjusted.
How does the drug MYMD-1 differ from other treatments for Duchenne muscular dystrophy?
The drug MYMD-1 is unique because it is part of a novel trial design that uses a small-sample, sequential, multiple assignment approach, which increases the efficiency of treatment effect estimates by enriching the placebo arm with external control data and using data from all stages. This method aims to improve the accuracy of drug development in rare diseases like Duchenne muscular dystrophy.12345
Research Team
Leonard Dunn, MD
Principal Investigator
Clinical Research of West Florida
Lon Lynn, DO
Principal Investigator
Clinical Research of West Florida
Jeremy Walston, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MYMD1 or placebo in a blinded fashion until the end-of-study visit on Day 28
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MYMD-1
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
TNF Pharmaceuticals, Inc.
Lead Sponsor
MyMD Pharmaceuticals, Inc.
Lead Sponsor