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NCT05660538
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
Conditions: Diabetic Peripheral Neuropathy
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE2
Enrollment: 175
Sponsor: Vertex Pharmaceuticals Incorporated
Location: United States
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
Eligibility Criteria
Key Inclusion Criteria:Diagnosis of diabetes mellitus type 1 or type 2 withGlycosylated hemoglobin A1c (HbA1c) ≤9%; andPresence of bilateral pain in lower extremities due to DPN for at least 1 yearKey Exclusion Criteria:Painful neuropathy other than DPNHistory of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 monthsOther protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05660538). StuddyBuddy aggregates publicly available trial information.
