Phase
Condition
Pain (Pediatric)
Neurologic Disorders
Pain
Treatment
Placebo (matched to pregabalin)
Placebo (matched to VX-993)
Pregabalin
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Centricity Research Brampton
Brampton,
CanadaActive - Recruiting
LMC Clinical Research Inc. d.b.a. Centricity Research
Brampton,
CanadaActive - Recruiting
Centricity Research Brampton
Brampton 5907364,
CanadaSite Not Available
OCT Research ULC
Kelowna,
CanadaActive - Recruiting
Okanagan Clinical Trials
Kelowna,
CanadaActive - Recruiting
OCT Research ULC
Kelowna 5990579,
CanadaSite Not Available
Altasciences - Beaumont Clinic Montreal
Montreal,
CanadaActive - Recruiting
Altasciences Montreal
Montreal,
CanadaActive - Recruiting
Altasciences - Beaumont Clinic Montreal
Montreal 6077243,
CanadaSite Not Available
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
Toronto,
CanadaActive - Recruiting
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
Toronto 6167865,
CanadaSite Not Available
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont Ferrand,
FranceSite Not Available
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
Clermont-Ferrand,
FranceActive - Recruiting
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand 3024635,
FranceActive - Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
Clermont-Ferrand 3024635,
FranceSite Not Available
CHU de Nîmes - Pain Assessment and Treatment Center
Nimes,
FranceSite Not Available
CHU de Nîmes - Pain Assessment and Treatment Center
Nîmes,
FranceActive - Recruiting
CHU de Nîmes - Pain Assessment and Treatment Center
Nîmes 2990363,
FranceSite Not Available
Hopital Cochin - Rheumatology
Paris,
FranceActive - Recruiting
Hôpital Cochin - Centre d'Evaluation et de Traitement de la Douleur (CETD)
Paris,
FranceActive - Recruiting
Hopital Cochin - Rheumatology
Paris 2988507,
FranceSite Not Available
North Hospital
Saint-Priest-en-Jarez,
FranceActive - Recruiting
North Hospital
Saint-Priest-en-Jarez 2977350,
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
St Priest en Jarez,
FranceActive - Recruiting
North Hospital
St Priest en Jarez,
FranceSite Not Available
Ruhr-Universitaet Bochum - Heart and Diabetes Center
Bad Oeynhausen,
GermanyActive - Recruiting
Ruhr-Universitaet Bochum - Heart and Diabetes Center
Bad Oeynhausen 2953386,
GermanySite Not Available
FutureMeds GmbH
Berlin,
GermanyActive - Recruiting
emovis GmbH
Berlin,
GermanySite Not Available
FutureMeds GmbH
Berlin 2950159,
GermanySite Not Available
FutureMeds Frankfurt
Offenbach/Main,
GermanyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan,
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
Milan,
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan 3173435,
ItalySite Not Available
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
Milan 6951411,
ItalySite Not Available
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
Birmingham,
United KingdomActive - Recruiting
FutureMeds Birmingham
Birmingham,
United KingdomActive - Recruiting
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
Birmingham 2655603,
United KingdomSite Not Available
FutureMeds Birmingham
Birmingham 2655603,
United KingdomActive - Recruiting
Ninewells Hospital
Dundee,
United KingdomActive - Recruiting
Ninewells Hospital - Endocrinology
Dundee,
United KingdomActive - Recruiting
Ninewells Hospital - Endocrinology
Dundee 2650752,
United KingdomSite Not Available
FutureMeds Glasgow
Glasgow,
United KingdomActive - Recruiting
FutureMeds Glasgow
Glasgow 2648579,
United KingdomSite Not Available
Aintree University Hospital
Liverpool,
United KingdomActive - Recruiting
University of Liverpool - Aintree University Hospital
Liverpool,
United KingdomActive - Recruiting
University of Liverpool - Aintree University Hospital
Liverpool 2644210,
United KingdomSite Not Available
St Pancras Clinical Research
London,
United KingdomActive - Recruiting
St Pancras Clinical Research
London 2643743,
United KingdomSite Not Available
Manchester Diabetes Centre (MDC)
Manchester,
United KingdomActive - Recruiting
Manchester Diabetes Centre (MDC)
Manchester 2643123,
United KingdomSite Not Available
CHU de Nîmes
Nimes,
United KingdomActive - Recruiting
George Eliot Hospital NHS Trust
Nuneaton,
United KingdomActive - Recruiting
George Eliot Hospital NHS Trust - Diabetes and Endocrinology Centre
Nuneaton,
United KingdomActive - Recruiting
George Eliot Hospital NHS Trust
Nuneaton 2641157,
United KingdomSite Not Available
Royal Hallamshire Hospital - Endocrinology
Sheffield,
United KingdomActive - Recruiting
Royal Hallamshire Hospital - Endocrinology
Sheffield 2638077,
United KingdomSite Not Available
Cullman Clinical Trials
Cullman, Alabama 35055
United StatesCompleted
Cullman Clinical Trials
Cullman 4057835, Alabama 4829764 35055
United StatesSite Not Available
Trovare Clinical Research
Bakersfield, California 93301
United StatesActive - Recruiting
Trovare Clinical Research - Bakersfield CA
Bakersfield, California 93301
United StatesCompleted
Eximia Research - San Diego
La Mesa, California 91942
United StatesCompleted
Eximia Research-CA, LLC
La Mesa, California 91942
United StatesActive - Recruiting
Trovare Clinical Research - Bakersfield CA
Bakersfield 5325738, California 5332921 93301
United StatesSite Not Available
Eximia Research - San Diego
La Mesa 5363990, California 5332921 91942
United StatesSite Not Available
Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge, Colorado 80033
United StatesCompleted
Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge 5443948, Colorado 5417618 80033
United StatesSite Not Available
Accel Research - Deland
DeLand, Florida 32720
United StatesCompleted
Accel Research Site - Deland Clinical Research Unit
DeLand, Florida 32720
United StatesActive - Recruiting
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida 33912
United StatesCompleted
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida 33009
United StatesCompleted
Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida 33009
United StatesSite Not Available
Health Awareness
Jupiter, Florida 33458
United StatesActive - Recruiting
Health Awareness, Inc., Jupiter
Jupiter, Florida 33458
United StatesCompleted
Suncoast Research Associates
Miami, Florida 33137
United StatesActive - Recruiting
Suncoast Research Associates - Miami
Miami, Florida 33172
United StatesCompleted
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United StatesSite Not Available
Innovation Medical Research Center - Palmetto
Palmetto Bay, Florida 33157
United StatesCompleted
Health Awareness - PSL
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, Florida 34952
United StatesCompleted
Accel Research - Deland
DeLand 4152890, Florida 4155751 32720
United StatesSite Not Available
AMR Fort Myers (The Clinical Study Center)
Fort Myers 4155995, Florida 4155751 33912
United StatesSite Not Available
Velocity Clinical Research - Hallandale Beach
Hallandale 4157898, Florida 4155751 33009
United StatesSite Not Available
Health Awareness, Inc., Jupiter
Jupiter 4160610, Florida 4155751 33458
United StatesSite Not Available
Suncoast Research Associates - Miami
Miami 4164138, Florida 4155751 33172
United StatesSite Not Available
Innovation Medical Research Center - Palmetto
Palmetto Bay 4167634, Florida 4155751 33157
United StatesSite Not Available
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie 4169171, Florida 4155751 34952
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesCompleted
ARSN - NeuroStudies
Decatur, Georgia 30030
United StatesActive - Recruiting
Accel Research - Decatur
Decatur, Georgia 30030
United StatesCompleted
Atlanta Center for Medical Research
Atlanta 4180439, Georgia 4197000 30331
United StatesSite Not Available
Accel Research - Decatur
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Velocity Clinical Research - Boise
Meridian, Idaho 83642
United StatesCompleted
Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho 83642
United StatesActive - Recruiting
Velocity Clinical Research - Boise
Meridian 5600685, Idaho 5596512 83642
United StatesSite Not Available
Healthcare Research Network - Flossmoor IL
Flossmoor, Illinois 604773027
United StatesCompleted
Healthcare Research Network II, LLC
Flossmoor, Illinois 60422
United StatesActive - Recruiting
Healthcare Research Network - Flossmoor IL
Flossmoor 4892684, Illinois 4896861 604773027
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesCompleted
Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
Healthcare Research Network
Hazelwood, Missouri 63042
United StatesActive - Recruiting
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri 63042
United StatesCompleted
Healthcare Research Network - Hazelwood MO
Hazelwood 4389967, Missouri 4398678 63042
United StatesSite Not Available
Eximia Clinical Research - NC
Raleigh, North Carolina 27607
United StatesActive - Recruiting
Eximia Research - Raleigh
Raleigh, North Carolina 27607
United StatesCompleted
Eximia Research - Raleigh
Raleigh 4487042, North Carolina 4482348 27607
United StatesSite Not Available
Velocity Clinical Research - Cleveland
Beachwood, Ohio 44122
United StatesCompleted
Velocity Clinical Research - Cleveland
Beachwood 5146711, Ohio 5165418 44122
United StatesSite Not Available
Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818
United StatesCompleted
Velocity Clinical Research - Providence
East Greenwich 5221875, Rhode Island 5224323 02818
United StatesSite Not Available
Clinical Trials of South Carolina - Berkeley
Moncks Corner, South Carolina 29461
United StatesActive - Recruiting
Clinical Trials of South Carolina - Berkeley - Moncks Corner
Moncks Corner, South Carolina 29461
United StatesCompleted
Clinical Trials of South Carolina - Berkeley - Moncks Corner
Moncks Corner 4587511, South Carolina 4597040 29461
United StatesSite Not Available
Gadolin Research
Beaumont, Texas 77702
United StatesCompleted
Velocity Clinical Research, Dallas
Dallas, Texas 75230
United StatesCompleted
San Antonio Clinical Trials
San Antonio, Texas 78240
United StatesCompleted
Gadolin Research
Beaumont 4672989, Texas 4736286 77702
United StatesSite Not Available
Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
San Antonio Clinical Trials
San Antonio 4726206, Texas 4736286 78240
United StatesSite Not Available
AMR Norfolk
Norfolk, Virginia 23502
United StatesCompleted
AMR Norfolk
Norfolk 4776222, Virginia 6254928 23502
United StatesSite Not Available

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