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

NCT06619860 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 2

Started

2024-10-18

Last updated

2026-06-01

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

VX-993PregabalinPlacebo (matched to pregabalin)Placebo (matched to VX-993)

VX-993: Tablets for oral administration.

Pregabalin: Capsules for oral administration.

Placebo (matched to pregabalin): Placebo matched to pregabalin for oral administration.

Placebo (matched to VX-993): Placebo matched to VX-993 for oral administration.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 — From Baseline up to Week 12

Trial sites (47)

Facility	City	Region	Status
Cullman Clinical Trials	Cullman	Alabama	Completed
Trovare Clinical Research - Bakersfield CA	Bakersfield	California	Completed
Eximia Research - San Diego	La Mesa	California	Completed
Paradigm Clincial Research Centers, LLC., Wheat Ridge	Wheat Ridge	Colorado	Completed
Accel Research - Deland	DeLand	Florida	Completed
AMR Fort Myers (The Clinical Study Center)	Fort Myers	Florida	Completed
Velocity Clinical Research - Hallandale Beach	Hallandale	Florida	Completed
Health Awareness, Inc., Jupiter	Jupiter	Florida	Completed
Suncoast Research Associates - Miami	Miami	Florida	Completed
Innovation Medical Research Center - Palmetto	Palmetto Bay	Florida	Completed
Health Awareness, Inc. - Port St. Lucie	Port Saint Lucie	Florida	Completed
Atlanta Center for Medical Research	Atlanta	Georgia	Completed
Accel Research - Decatur	Decatur	Georgia	Completed
Velocity Clinical Research - Boise	Meridian	Idaho	Completed
Healthcare Research Network - Flossmoor IL	Flossmoor	Illinois	Completed
Quest Research Institute	Farmington Hills	Michigan	Completed
Healthcare Research Network - Hazelwood MO	Hazelwood	Missouri	Completed
Eximia Research - Raleigh	Raleigh	North Carolina	Completed
Velocity Clinical Research - Cleveland	Beachwood	Ohio	Completed
Velocity Clinical Research - Providence	East Greenwich	Rhode Island	Completed
Clinical Trials of South Carolina - Berkeley - Moncks Corner	Moncks Corner	South Carolina	Completed
Gadolin Research	Beaumont	Texas	Completed
Velocity Clinical Research, Dallas	Dallas	Texas	Completed
San Antonio Clinical Trials	San Antonio	Texas	Completed
AMR Norfolk	Norfolk	Virginia	Completed
Centricity Research Brampton	Brampton	Canada	Recruiting
OCT Research ULC	Kelowna	Canada	Recruiting
Altasciences - Beaumont Clinic Montreal	Montreal	Canada	Recruiting
Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)	Toronto	Canada	Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied	Clermont-Ferrand	France	Recruiting
CHU de Nîmes - Pain Assessment and Treatment Center	Nîmes	France	Recruiting
Hopital Cochin - Rheumatology	Paris	France	Recruiting
North Hospital	Saint-Priest-en-Jarez	France	Recruiting
Ruhr-Universitaet Bochum - Heart and Diabetes Center	Bad Oeynhausen	Germany	Recruiting
FutureMeds GmbH	Berlin	Germany	Recruiting
FutureMeds Frankfurt	Offenbach/Main	Germany	Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta	Milan	Italy	Recruiting
IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience	Milan	Italy	Recruiting
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU	Birmingham	United Kingdom	Recruiting
FutureMeds Birmingham	Birmingham	United Kingdom	Recruiting

+ 7 more sites — see the full list on the official registry below.

On this site

📄 Lyrica (pregabalin) drug profile →

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Other trials for the same condition

MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP Recruiting

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain Recruiting

Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) Active, not recruiting

Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619860 on ClinicalTrials.gov ↗ ← All trials in the USA