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Completed
NCT05166109
A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
Conditions: Becker Muscular Dystrophy
Sex: Male
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 46
Sponsor: ReveraGen BioPharma, Inc.
Location: University of Pittsburgh Pittsburgh Pennsylvania
Summary
This Phase II pilot study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, PD, and exploratory clinical efficacy of vamorolone 500mg (250mg for body weight \
Eligibility Criteria
Inclusion Criteria:
1. Subject or Subject's parent(s) or legal guardian (s) has (have) provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures;
2. Subject is a male and has a confirmed diagnosis of Becker dystrophy as defined as:
1. Identifiable mutation within the DMD gene (deletion/duplication of one or more exons), where reading frame can be predicted as 'in-frame', and clinical picture consistent with Becker dystrophy, OR
2. Complete dystrophin gene sequencing showing an alteration (small mutation, duplication, other) that is expected to allow production of an internally deleted dystrophin protein, with a typical clinical picture of Becker dystrophy;
3. Subject is ≥ 18 years of age and \
Source: ClinicalTrials.gov (NCT05166109). StuddyBuddy aggregates publicly available trial information.