Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
Phase 2 – studying effectiveness and dosage
Conditions:
Diabetic Peripheral Neuropathic Pain
Sponsor: Vertex Pharmaceuticals Incorporated
trial.available_in:
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Overview
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)
Who can participate
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
VX-993
DRUG
Pregabalin
DRUG
Placebo (matched to pregabalin)
DRUG
Placebo (matched to VX-993)
DRUG
Locations
47
Canada (4)
Centricity Research Brampton
Brampton
OCT Research ULC
Kelowna
Altasciences - Beaumont Clinic Montreal
Montreal
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
Toronto
France (4)
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
Clermont-Ferrand
CHU de Nîmes - Pain Assessment and Treatment Center
Nîmes
Hopital Cochin - Rheumatology
Paris
North Hospital
Saint-Priest-en-Jarez
Germany (3)
Ruhr-Universitaet Bochum - Heart and Diabetes Center
Bad Oeynhausen
FutureMeds GmbH
Berlin
FutureMeds Frankfurt
Offenbach/Main
Italy (2)
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
Milan
United Kingdom (9)
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
Birmingham
FutureMeds Birmingham
Birmingham
Ninewells Hospital - Endocrinology
Dundee
FutureMeds Glasgow
Glasgow
University of Liverpool - Aintree University Hospital
Liverpool
St Pancras Clinical Research
London
Manchester Diabetes Centre (MDC)
Manchester
George Eliot Hospital NHS Trust
Nuneaton
Royal Hallamshire Hospital - Endocrinology
Sheffield
United States (25)
Atlanta Center for Medical Research
Atlanta , Georgia
COMPLETED
Trovare Clinical Research - Bakersfield CA
Bakersfield , California
COMPLETED
Velocity Clinical Research - Cleveland
Beachwood , Ohio
COMPLETED
Gadolin Research
Beaumont , Texas
COMPLETED
Cullman Clinical Trials
Cullman , Alabama
COMPLETED
Velocity Clinical Research, Dallas
Dallas , Texas
COMPLETED
Accel Research - Decatur
Decatur , Georgia
COMPLETED
Accel Research - Deland
DeLand , Florida
COMPLETED
Velocity Clinical Research - Providence
East Greenwich , Rhode Island
COMPLETED
Quest Research Institute
Farmington Hills , Michigan
COMPLETED
Healthcare Research Network - Flossmoor IL
Flossmoor , Illinois
COMPLETED
AMR Fort Myers (The Clinical Study Center)
Fort Myers , Florida
COMPLETED
Velocity Clinical Research - Hallandale Beach
Hallandale , Florida
COMPLETED
Healthcare Research Network - Hazelwood MO
Hazelwood , Missouri
COMPLETED
Health Awareness, Inc., Jupiter
Jupiter , Florida
COMPLETED
Eximia Research - San Diego
La Mesa , California
COMPLETED
Velocity Clinical Research - Boise
Meridian , Idaho
COMPLETED
Suncoast Research Associates - Miami
Miami , Florida
COMPLETED
Clinical Trials of South Carolina - Berkeley - Moncks Corner
Moncks Corner , South Carolina
COMPLETED
AMR Norfolk
Norfolk , Virginia
COMPLETED
Innovation Medical Research Center - Palmetto
Palmetto Bay , Florida
COMPLETED
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie , Florida
COMPLETED
Eximia Research - Raleigh
Raleigh , North Carolina
COMPLETED
San Antonio Clinical Trials
San Antonio , Texas
COMPLETED
Paradigm Clincial Research Centers, LLC., Wheat Ridge
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