Trials Today

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

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

Diabetic Peripheral Neuropathic Pain

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

Arm	Description	Assigned 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, Alabama 35055

Trovare Clinical Research
Bakersfield, California 93301

Eximia Research-CA, LLC
La Mesa, California 91942

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

Accel Research Site - Deland Clinical Research Unit
DeLand, Florida 32720

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

Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida 33009

Health Awareness, Inc., Jupiter
Jupiter, Florida 33458

Suncoast Research Associates - Miami
Miami, Florida 33137

Innovation Medical Research Center
Palmetto Bay, Florida 33157

Health Awareness - PSL
Port Saint Lucie, Florida 34952

Atlanta Center for Medical Research
Atlanta, Georgia 30331

ARSN - NeuroStudies
Decatur, Georgia 30030

Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho 83642

Healthcare Research Network II, LLC
Flossmoor, Illinois 60422

Quest Research Institute
Farmington Hills, Michigan 48334

Healthcare Research Network
Hazelwood, Missouri 63042

Eximia Research - Raleigh
Raleigh, North Carolina 27607

Velocity Clinical Research - Cleveland
Beachwood, Ohio 44122

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

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

Gadolin Research
Beaumont, Texas 77702

Velocity Clinical Research, Dallas
Dallas, Texas 75230

San Antonio Clinical Trials
San Antonio, Texas 78240

AMR Norfolk
Norfolk, Virginia 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.