Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVertex Pharmaceuticals Incorporated

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VX-993
  • Pregabalin
  • Placebo (matched to pregabalin)
  • Placebo (matched to VX-993)

Treatment groups

300 Participants
are divided into 2 treatment groups