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

Description

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)

Conditions

Diabetic Peripheral Neuropathic Pain

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Diabetic Peripheral Neuropathic Pain
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Trovare Clinical Research, Bakersfield, California, United States, 93301

Atlanta

Atlanta Center for Medical Research, Atlanta, Georgia, United States, 30331

Meridian

Velocity Clinical Research - Boise (Advanced Clinical Research), Meridian, Idaho, United States, 83642

Flossmoor

Healthcare Research Network II, LLC, Flossmoor, Illinois, United States, 60422

Hazelwood

Healthcare Research Network, Hazelwood, Missouri, United States, 63042

Dallas

Velocity Clinical Research, Dallas, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2026-05