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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Pregabalin

Criteria

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.