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
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Cullman Clinical Trials
RECRUITING
Cullman
California
Trovare Clinical Research - Bakersfield CA
COMPLETED
Bakersfield
Eximia Research - San Diego
RECRUITING
La Mesa
Colorado
Paradigm Clincial Research Centers, LLC., Wheat Ridge
RECRUITING
Wheat Ridge
Florida
Accel Research - Deland
RECRUITING
Deland
AMR Fort Myers (The Clinical Study Center)
RECRUITING
Fort Myers
Velocity Clinical Research - Hallandale Beach
RECRUITING
Hallandale
Health Awareness, Inc., Jupiter
RECRUITING
Jupiter
Suncoast Research Associates - Miami
RECRUITING
Miami
Innovation Medical Research Center - Palmetto
COMPLETED
Palmetto Bay
Health Awareness, Inc. - Port St. Lucie
RECRUITING
Port Saint Lucie
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Accel Research - Decatur
RECRUITING
Decatur
Idaho
Velocity Clinical Research - Boise
RECRUITING
Meridian
Illinois
Healthcare Research Network - Flossmoor IL
RECRUITING
Flossmoor
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Missouri
Healthcare Research Network - Hazelwood MO
RECRUITING
Hazelwood
North Carolina
Eximia Research - Raleigh
RECRUITING
Raleigh
Ohio
Velocity Clinical Research - Cleveland
RECRUITING
Beachwood
Rhode Island
Velocity Clinical Research - Providence
RECRUITING
East Greenwich
South Carolina
Clinical Trials of South Carolina - Berkeley - Moncks Corner
RECRUITING
Moncks Corner
Texas
Gadolin Research
RECRUITING
Beaumont
Velocity Clinical Research, Dallas
RECRUITING
Dallas
San Antonio Clinical Trials
RECRUITING
San Antonio
Virginia
AMR Norfolk
RECRUITING
Norfolk
Other Locations
Canada
Centricity Research Brampton
RECRUITING
Brampton
OCT Research ULC
RECRUITING
Kelowna
Altasciences - Beaumont Clinic Montreal
RECRUITING
Montreal
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
RECRUITING
Toronto
France
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
RECRUITING
Clermont-ferrand
CHU de Nîmes - Pain Assessment and Treatment Center
RECRUITING
Nîmes
Hopital Cochin - Rheumatology
RECRUITING
Paris
North Hospital
RECRUITING
Saint-priest-en-jarez
Germany
Ruhr-Universitaet Bochum - Heart and Diabetes Center
RECRUITING
Bad Oeynhausen
FutureMeds GmbH
RECRUITING
Berlin
FutureMeds Frankfurt
RECRUITING
Offenbach/main
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience
RECRUITING
Milan
United Kingdom
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
RECRUITING
Birmingham
FutureMeds Birmingham
RECRUITING
Birmingham
Ninewells Hospital - Endocrinology
RECRUITING
Dundee
FutureMeds Glasgow
RECRUITING
Glasgow
University of Liverpool - Aintree University Hospital
RECRUITING
Liverpool
St Pancras Clinical Research
RECRUITING
London
George Eliot Hospital NHS Trust
RECRUITING
Nuneaton
Royal Hallamshire Hospital - Endocrinology
RECRUITING
Sheffield
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 300
Treatments
Experimental: VX-993
Participants will be randomized to receive multiple doses of different dose levels of VX-993.
Active_comparator: Pregabalin
Participants will be randomized to receive Pregabalin.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated