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NCT06619860PHASE2Recruiting

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

Vertex Pharmaceuticals Incorporated

Start Date

10/18/2024

Completion Date

4/22/2027

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

Age Range: 18 years to 80 years

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 a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year 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 or stroke, within the past 12 months Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

VX-993

DRUG

Pregabalin

DRUG

Placebo (matched to pregabalin)

DRUG

Placebo (matched to VX-993)

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Conditions

Diabetic Peripheral Neuropathic Pain

Locations

Cullman Clinical Trials

Cullman, Alabama 35055

United States

Trovare Clinical Research - Bakersfield CA

Bakersfield, California 93301

United States

Eximia Research - San Diego

La Mesa, California 91942

United States

Paradigm Clincial Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado 80033

United States

Accel Research - Deland

DeLand, Florida 32720

United States

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida 33912

United States

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida 33009

United States

Health Awareness, Inc., Jupiter

Jupiter, Florida 33458

United States

Suncoast Research Associates - Miami

Miami, Florida 33172

United States

Innovation Medical Research Center - Palmetto

Palmetto Bay, Florida 33157

United States

Health Awareness, Inc. - Port St. Lucie

Port Saint Lucie, Florida 34952

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Accel Research - Decatur

Decatur, Georgia 30030

United States

Velocity Clinical Research - Boise

Meridian, Idaho 83642

United States

Healthcare Research Network - Flossmoor IL

Flossmoor, Illinois 604773027

United States

Quest Research Institute

Farmington Hills, Michigan 48334

United States

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri 63042

United States

Eximia Research - Raleigh

Raleigh, North Carolina 27607

United States

Velocity Clinical Research - Cleveland

Beachwood, Ohio 44122

United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island 02818

United States

Clinical Trials of South Carolina - Berkeley - Moncks Corner

Moncks Corner, South Carolina 29461

United States

Gadolin Research

Beaumont, Texas 77702

United States

Velocity Clinical Research, Dallas

Dallas, Texas 75230

United States

San Antonio Clinical Trials

San Antonio, Texas 78240

United States

AMR Norfolk

Norfolk, Virginia 23502

United States

Centricity Research Brampton

Brampton,

Canada

OCT Research ULC

Kelowna,

Canada

Altasciences - Beaumont Clinic Montreal

Montreal,

Canada

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

Toronto,

Canada

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

Clermont-Ferrand,

France

CHU de Nîmes - Pain Assessment and Treatment Center

Nîmes,

France

Hopital Cochin - Rheumatology

Paris,

France

North Hospital

Saint-Priest-en-Jarez,

France

Ruhr-Universitaet Bochum - Heart and Diabetes Center

Bad Oeynhausen,

Germany

FutureMeds GmbH

Berlin,

Germany

FutureMeds Frankfurt

Offenbach/Main,

Germany

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan,

Italy

IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience

Milan,

Italy

Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU

Birmingham,

United Kingdom

FutureMeds Birmingham

Birmingham,

United Kingdom

Ninewells Hospital - Endocrinology

Dundee,

United Kingdom

FutureMeds Glasgow

Glasgow,

United Kingdom

University of Liverpool - Aintree University Hospital

Liverpool,

United Kingdom

St Pancras Clinical Research

London,

United Kingdom

Manchester Diabetes Centre (MDC)

Manchester,

United Kingdom

George Eliot Hospital NHS Trust

Nuneaton,

United Kingdom

Royal Hallamshire Hospital - Endocrinology

Sheffield,

United Kingdom