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:
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
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.
