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

Last updated: March 13, 2026
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Pain (Pediatric)

Neurologic Disorders

Pain

Treatment

Placebo (matched to pregabalin)

Placebo (matched to VX-993)

Pregabalin

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: Placebo (matched to pregabalin)
Phase: 2
Study Start date:
October 18, 2024
Estimated Completion Date:
May 30, 2026

Connect with a study center

  • Centricity Research Brampton

    Brampton,
    Canada

    Active - Recruiting

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

    Brampton,
    Canada

    Active - Recruiting

  • Centricity Research Brampton

    Brampton 5907364,
    Canada

    Site Not Available

  • OCT Research ULC

    Kelowna,
    Canada

    Active - Recruiting

  • Okanagan Clinical Trials

    Kelowna,
    Canada

    Active - Recruiting

  • OCT Research ULC

    Kelowna 5990579,
    Canada

    Site Not Available

  • Altasciences - Beaumont Clinic Montreal

    Montreal,
    Canada

    Active - Recruiting

  • Altasciences Montreal

    Montreal,
    Canada

    Active - Recruiting

  • Altasciences - Beaumont Clinic Montreal

    Montreal 6077243,
    Canada

    Site Not Available

  • Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)

    Toronto,
    Canada

    Active - Recruiting

  • Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)

    Toronto 6167865,
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont Ferrand,
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand 3024635,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied

    Clermont-Ferrand 3024635,
    France

    Site Not Available

  • CHU de Nîmes - Pain Assessment and Treatment Center

    Nimes,
    France

    Site Not Available

  • CHU de Nîmes - Pain Assessment and Treatment Center

    Nîmes,
    France

    Active - Recruiting

  • CHU de Nîmes - Pain Assessment and Treatment Center

    Nîmes 2990363,
    France

    Site Not Available

  • Hopital Cochin - Rheumatology

    Paris,
    France

    Active - Recruiting

  • Hôpital Cochin - Centre d'Evaluation et de Traitement de la Douleur (CETD)

    Paris,
    France

    Active - Recruiting

  • Hopital Cochin - Rheumatology

    Paris 2988507,
    France

    Site Not Available

  • North Hospital

    Saint-Priest-en-Jarez,
    France

    Active - Recruiting

  • North Hospital

    Saint-Priest-en-Jarez 2977350,
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    St Priest en Jarez,
    France

    Active - Recruiting

  • North Hospital

    St Priest en Jarez,
    France

    Site Not Available

  • Ruhr-Universitaet Bochum - Heart and Diabetes Center

    Bad Oeynhausen,
    Germany

    Active - Recruiting

  • Ruhr-Universitaet Bochum - Heart and Diabetes Center

    Bad Oeynhausen 2953386,
    Germany

    Site Not Available

  • FutureMeds GmbH

    Berlin,
    Germany

    Active - Recruiting

  • emovis GmbH

    Berlin,
    Germany

    Site Not Available

  • FutureMeds GmbH

    Berlin 2950159,
    Germany

    Site Not Available

  • FutureMeds Frankfurt

    Offenbach/Main,
    Germany

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan,
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience

    Milan,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan 3173435,
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience

    Milan 6951411,
    Italy

    Site Not Available

  • Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU

    Birmingham,
    United Kingdom

    Active - Recruiting

  • FutureMeds Birmingham

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU

    Birmingham 2655603,
    United Kingdom

    Site Not Available

  • FutureMeds Birmingham

    Birmingham 2655603,
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital

    Dundee,
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital - Endocrinology

    Dundee,
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital - Endocrinology

    Dundee 2650752,
    United Kingdom

    Site Not Available

  • FutureMeds Glasgow

    Glasgow,
    United Kingdom

    Active - Recruiting

  • FutureMeds Glasgow

    Glasgow 2648579,
    United Kingdom

    Site Not Available

  • Aintree University Hospital

    Liverpool,
    United Kingdom

    Active - Recruiting

  • University of Liverpool - Aintree University Hospital

    Liverpool,
    United Kingdom

    Active - Recruiting

  • University of Liverpool - Aintree University Hospital

    Liverpool 2644210,
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research

    London,
    United Kingdom

    Active - Recruiting

  • St Pancras Clinical Research

    London 2643743,
    United Kingdom

    Site Not Available

  • Manchester Diabetes Centre (MDC)

    Manchester,
    United Kingdom

    Active - Recruiting

  • Manchester Diabetes Centre (MDC)

    Manchester 2643123,
    United Kingdom

    Site Not Available

  • CHU de Nîmes

    Nimes,
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital NHS Trust

    Nuneaton,
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital NHS Trust - Diabetes and Endocrinology Centre

    Nuneaton,
    United Kingdom

    Active - Recruiting

  • George Eliot Hospital NHS Trust

    Nuneaton 2641157,
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital - Endocrinology

    Sheffield,
    United Kingdom

    Active - Recruiting

  • Royal Hallamshire Hospital - Endocrinology

    Sheffield 2638077,
    United Kingdom

    Site Not Available

  • Cullman Clinical Trials

    Cullman, Alabama 35055
    United States

    Completed

  • Cullman Clinical Trials

    Cullman 4057835, Alabama 4829764 35055
    United States

    Site Not Available

  • Trovare Clinical Research

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Trovare Clinical Research - Bakersfield CA

    Bakersfield, California 93301
    United States

    Completed

  • Eximia Research - San Diego

    La Mesa, California 91942
    United States

    Completed

  • Eximia Research-CA, LLC

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Trovare Clinical Research - Bakersfield CA

    Bakersfield 5325738, California 5332921 93301
    United States

    Site Not Available

  • Eximia Research - San Diego

    La Mesa 5363990, California 5332921 91942
    United States

    Site Not Available

  • Paradigm Clincial Research Centers, LLC., Wheat Ridge

    Wheat Ridge, Colorado 80033
    United States

    Completed

  • Paradigm Clincial Research Centers, LLC., Wheat Ridge

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Site Not Available

  • Accel Research - Deland

    DeLand, Florida 32720
    United States

    Completed

  • 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

    Completed

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida 33009
    United States

    Completed

  • Velocity Clinical Research - Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Health Awareness

    Jupiter, Florida 33458
    United States

    Active - Recruiting

  • Health Awareness, Inc., Jupiter

    Jupiter, Florida 33458
    United States

    Completed

  • Suncoast Research Associates

    Miami, Florida 33137
    United States

    Active - Recruiting

  • Suncoast Research Associates - Miami

    Miami, Florida 33172
    United States

    Completed

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Innovation Medical Research Center - Palmetto

    Palmetto Bay, Florida 33157
    United States

    Completed

  • Health Awareness - PSL

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • Health Awareness, Inc. - Port St. Lucie

    Port Saint Lucie, Florida 34952
    United States

    Completed

  • Accel Research - Deland

    DeLand 4152890, Florida 4155751 32720
    United States

    Site Not Available

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach

    Hallandale 4157898, Florida 4155751 33009
    United States

    Site Not Available

  • Health Awareness, Inc., Jupiter

    Jupiter 4160610, Florida 4155751 33458
    United States

    Site Not Available

  • Suncoast Research Associates - Miami

    Miami 4164138, Florida 4155751 33172
    United States

    Site Not Available

  • Innovation Medical Research Center - Palmetto

    Palmetto Bay 4167634, Florida 4155751 33157
    United States

    Site Not Available

  • Health Awareness, Inc. - Port St. Lucie

    Port Saint Lucie 4169171, Florida 4155751 34952
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Completed

  • ARSN - NeuroStudies

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Accel Research - Decatur

    Decatur, Georgia 30030
    United States

    Completed

  • Atlanta Center for Medical Research

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Accel Research - Decatur

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Velocity Clinical Research - Boise

    Meridian, Idaho 83642
    United States

    Completed

  • Velocity Clinical Research - Boise (Advanced Clinical Research)

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Velocity Clinical Research - Boise

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Healthcare Research Network - Flossmoor IL

    Flossmoor, Illinois 604773027
    United States

    Completed

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

    Active - Recruiting

  • Healthcare Research Network - Flossmoor IL

    Flossmoor 4892684, Illinois 4896861 604773027
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Completed

  • Quest Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Active - Recruiting

  • Healthcare Research Network - Hazelwood MO

    Hazelwood, Missouri 63042
    United States

    Completed

  • Healthcare Research Network - Hazelwood MO

    Hazelwood 4389967, Missouri 4398678 63042
    United States

    Site Not Available

  • Eximia Clinical Research - NC

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Eximia Research - Raleigh

    Raleigh, North Carolina 27607
    United States

    Completed

  • Eximia Research - Raleigh

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio 44122
    United States

    Completed

  • Velocity Clinical Research - Cleveland

    Beachwood 5146711, Ohio 5165418 44122
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Completed

  • Velocity Clinical Research - Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • Clinical Trials of South Carolina - Berkeley

    Moncks Corner, South Carolina 29461
    United States

    Active - Recruiting

  • Clinical Trials of South Carolina - Berkeley - Moncks Corner

    Moncks Corner, South Carolina 29461
    United States

    Completed

  • Clinical Trials of South Carolina - Berkeley - Moncks Corner

    Moncks Corner 4587511, South Carolina 4597040 29461
    United States

    Site Not Available

  • Gadolin Research

    Beaumont, Texas 77702
    United States

    Completed

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Completed

  • San Antonio Clinical Trials

    San Antonio, Texas 78240
    United States

    Completed

  • Gadolin Research

    Beaumont 4672989, Texas 4736286 77702
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • San Antonio Clinical Trials

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

  • AMR Norfolk

    Norfolk, Virginia 23502
    United States

    Completed

  • AMR Norfolk

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

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