A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Sex: Male

Ages: 4 Years – 6 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 36

Sponsor: Grünenthal GmbH

Summary

This Phase 2 clinical trial will evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of tegacorat oral solution in male participants 4 to less than 7 years of age with Duchenne muscular dystrophy (DMD). Participants will be randomized to one of three tegacorat treatment groups during a 24-week Core Phase. Participants who complete the Core Phase will continue into a 72-week Extension Phase. The study will assess muscle function, ambulatory performance, safety outcomes, pharmacokinetics, pharmacodynamic biomarkers, and health-related quality of life over a total treatment period of up to 96 weeks.

Eligibility Criteria

INCLUSION CRITERIA: * Male participant aged ≥4 years and \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07911995). StuddyBuddy aggregates publicly available trial information.