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Trial completed
Phase 2
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

ClinicalTrials.gov Identifier
NCT05660538
Eligibility criteria
Sex
Age
18 Years - 80 Years
Phase
2
Key inclusion criteria
  • Diagnosis of diabetes mellitus type 1 or type 2 with
  • Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
  • Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Key exclusion criteria
  • Painful neuropathy other than DPN
  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
Other protocol defined Inclusion/Exclusion criteria may apply.
Trial details
Condition
Diabetic Peripheral Neuropathy
Study duration
December 2022 - October 2023
Study type
Interventional
Intervention/Treatment
Drug : VX-548, Drug : Pregabalin, Drug : Placebo (matched to VX-548), Drug : Placebo (matched to pregabalin)
Estimated enrollment
192

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