Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
TITLE:
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy
MEDICAL CONDITION: Diabetic Peripheral Neuropathy
AGE: 18-80yrs
SEX/GENDER: All
OVERVIEW
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
STUDY DETAILS
Inclusion Criteria:
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Diagnosis of diabetes mellitus type 1 or type 2 with
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Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
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Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Exclusion Criteria:
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Painful neuropathy other than DPN
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History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
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History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months