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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-993 		Participants will be randomized to receive multiple doses of different dose levels of VX-993.
  • Drug: VX-993
    Tablets for oral administration.
  • Drug: Placebo (matched to pregabalin)
    Placebo matched to pregabalin for oral administration.
Active Comparator
Pregabalin 		Participants will be randomized to receive Pregabalin.
  • Drug: Pregabalin
    Capsules for oral administration.
  • Drug: Placebo (matched to VX-993)
    Placebo matched to VX-993 for oral administration.

Recruiting Locations

Cullman Clinical Trials
Cullman 4057835, Alabama 4829764 35055

Trovare Clinical Research - Bakersfield CA
Bakersfield 5325738, California 5332921 93301

Eximia Research - San Diego
La Mesa 5363990, California 5332921 91942

Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge 5443948, Colorado 5417618 80033

Accel Research - Deland
DeLand 4152890, Florida 4155751 32720

AMR Fort Myers (The Clinical Study Center)
Fort Myers 4155995, Florida 4155751 33912

Velocity Clinical Research - Hallandale Beach
Hallandale 4157898, Florida 4155751 33009

Health Awareness, Inc., Jupiter
Jupiter 4160610, Florida 4155751 33458

Suncoast Research Associates - Miami
Miami 4164138, Florida 4155751 33172

Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie 4169171, Florida 4155751 34952

Atlanta Center for Medical Research
Atlanta 4180439, Georgia 4197000 30331

Accel Research - Decatur
Decatur 4191124, Georgia 4197000 30030

Velocity Clinical Research - Boise
Meridian 5600685, Idaho 5596512 83642

Healthcare Research Network - Flossmoor IL
Flossmoor 4892684, Illinois 4896861 60422

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

Healthcare Research Network - Hazelwood MO
Hazelwood 4389967, Missouri 4398678 63042

Eximia Research - Raleigh
Raleigh 4487042, North Carolina 4482348 27607

Velocity Clinical Research - Cleveland
Beachwood 5146711, Ohio 5165418 44122

Velocity Clinical Research - Providence
East Greenwich 5221875, Rhode Island 5224323 02818

Clinical Trials of South Carolina - Berkeley - Moncks Corner
Moncks Corner 4587511, South Carolina 4597040 29461

Gadolin Research
Beaumont 4672989, Texas 4736286 77702

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230

San Antonio Clinical Trials
San Antonio 4726206, Texas 4736286 78240

AMR Norfolk
Norfolk 4776222, Virginia 6254928 23502

More Details

NCT ID
NCT06619860
Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center