A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals Incorporated

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Diagnosis of diabetes mellitus type 1 or type 2 with * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) 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 Inclusio…

Interventions

Drug
VX-993
Tablets for oral administration.
Drug
Pregabalin
Capsules for oral administration.
Drug
Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Drug
Placebo (matched to VX-993)
Placebo matched to VX-993 for oral administration.

Locations (47)

Cullman Clinical Trials
Cullman, Alabama
Trovare Clinical Research - Bakersfield CA
Bakersfield, California
Eximia Research - San Diego
La Mesa, California
Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge, Colorado
Accel Research - Deland
DeLand, Florida
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida