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

Last updated: April 4, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Pain (Pediatric)

Pain

Neurologic Disorders

Treatment

Pregabalin

Placebo (matched to pregabalin)

Placebo (matched to VX-993)

Clinical Study ID

NCT06619860
VX24-993-103
2024-514689-38-01
EU CT Number
2024-514689-38-00
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 asymmetric, length-dependent sensory or sensorimotor polyneuropathy) for atleast 1 year

Exclusion

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 orstroke, within the past 12 months

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 300
Treatment Group(s): 4
Primary Treatment: Pregabalin
Phase: 2
Study Start date:
October 18, 2024
Estimated Completion Date:
May 30, 2026

Connect with a study center

  • LMC Clinical Research Inc. d.b.a. Centricity Research

    Brampton,
    Canada

    Active - Recruiting

  • Okanagan Clinical Trials

    Kelowna,
    Canada

    Active - Recruiting

  • Cullman Clinical Trials

    Cullman, Alabama 35055
    United States

    Active - Recruiting

  • Trovare Clinical Research

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Eximia Research-CA, LLC

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Paradigm Clincial Research Centers, LLC., Wheat Ridge

    Wheat Ridge, Colorado 80033
    United States

    Active - Recruiting

  • Accel Research Site - Deland Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Velocity Clinical Research - Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Active - Recruiting

  • Health Awareness

    Jupiter, Florida 33458
    United States

    Active - Recruiting

  • Suncoast Research Associates

    Miami, Florida 33137
    United States

    Active - Recruiting

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Health Awareness - PSL

    Port Saint Lucie, Florida 34952
    United States

    Active - Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • ARSN - NeuroStudies

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Velocity Clinical Research - Boise (Advanced Clinical Research)

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Active - Recruiting

  • Eximia Clinical Research - NC

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Clinical Trials of South Carolina - Berkeley

    Moncks Corner, South Carolina 29461
    United States

    Active - Recruiting

  • Gadolin Research

    Beaumont, Texas 77702
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • San Antonio Clinical Trials

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • AMR Norfolk

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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