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RECRUITING
NCT06619860
PHASE2

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

Sponsor: Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-10-18

Completion Date

2026-05-30

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

VX-993

Tablets for oral administration.

DRUG

Pregabalin

Capsules for oral administration.

DRUG

Placebo (matched to pregabalin)

Placebo matched to pregabalin for oral administration.

DRUG

Placebo (matched to VX-993)

Placebo matched to VX-993 for oral administration.

Locations (47)

Cullman Clinical Trials

Cullman, Alabama, United States

Trovare Clinical Research - Bakersfield CA

Bakersfield, California, United States

Eximia Research - San Diego

La Mesa, California, United States

Paradigm Clincial Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, United States

Accel Research - Deland

DeLand, Florida, United States

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida, United States

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, United States

Health Awareness, Inc., Jupiter

Jupiter, Florida, United States

Suncoast Research Associates - Miami

Miami, Florida, United States

Innovation Medical Research Center - Palmetto

Palmetto Bay, Florida, United States

Health Awareness, Inc. - Port St. Lucie

Port Saint Lucie, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Accel Research - Decatur

Decatur, Georgia, United States

Velocity Clinical Research - Boise

Meridian, Idaho, United States

Healthcare Research Network - Flossmoor IL

Flossmoor, Illinois, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri, United States

Eximia Research - Raleigh

Raleigh, North Carolina, United States

Velocity Clinical Research - Cleveland

Beachwood, Ohio, United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, United States

Clinical Trials of South Carolina - Berkeley - Moncks Corner

Moncks Corner, South Carolina, United States

Gadolin Research

Beaumont, Texas, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

San Antonio Clinical Trials

San Antonio, Texas, United States

AMR Norfolk

Norfolk, Virginia, 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