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

NCT06619860 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: VX24-993-1032024-514689-38-01
• Study Type: interventional
• Target: 300
• Locations: 6 countries
• Sites: 47

Brief 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)

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

  From Baseline up to Week 12

• Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

  From Baseline up to Week 12

• Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

  From Baseline up to Week 12

• Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to Week 16

Study Arms (2)

VX-993

EXPERIMENTAL

Participants will be randomized to receive multiple doses of different dose levels of VX-993.

Drug: VX-993; Drug: Placebo (matched to pregabalin)

Pregabalin

ACTIVE COMPARATOR

Participants will be randomized to receive Pregabalin.

Drug: Pregabalin; Drug: Placebo (matched to VX-993)

Interventions

VX-993 DRUG

Tablets for oral administration.

VX-993

Pregabalin DRUG

Capsules for oral administration.

Pregabalin

Placebo (matched to pregabalin) DRUG

Placebo matched to pregabalin for oral administration.

VX-993

Placebo (matched to VX-993) DRUG

Placebo matched to VX-993 for oral administration.

Pregabalin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (47)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

COMPLETED

Trovare Clinical Research - Bakersfield CA

Bakersfield, California, 93301, United States

COMPLETED

Eximia Research - San Diego

La Mesa, California, 91942, United States

COMPLETED

Paradigm Clincial Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

COMPLETED

Accel Research - Deland

DeLand, Florida, 32720, United States

COMPLETED

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida, 33912, United States

COMPLETED

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, 33009, United States

COMPLETED

Health Awareness, Inc., Jupiter

Jupiter, Florida, 33458, United States

COMPLETED

Suncoast Research Associates - Miami

Miami, Florida, 33172, United States

COMPLETED

Innovation Medical Research Center - Palmetto

Palmetto Bay, Florida, 33157, United States

COMPLETED

Health Awareness, Inc. - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

COMPLETED

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

COMPLETED

Accel Research - Decatur

Decatur, Georgia, 30030, United States

COMPLETED

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

COMPLETED

Healthcare Research Network - Flossmoor IL

Flossmoor, Illinois, 604773027, United States

COMPLETED

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

COMPLETED

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri, 63042, United States

COMPLETED

Eximia Research - Raleigh

Raleigh, North Carolina, 27607, United States

COMPLETED

Velocity Clinical Research - Cleveland

Beachwood, Ohio, 44122, United States

COMPLETED

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

COMPLETED

Clinical Trials of South Carolina - Berkeley - Moncks Corner

Moncks Corner, South Carolina, 29461, United States

COMPLETED

Gadolin Research

Beaumont, Texas, 77702, United States

COMPLETED

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

COMPLETED

San Antonio Clinical Trials

San Antonio, Texas, 78240, United States

COMPLETED

AMR Norfolk

Norfolk, Virginia, 23502, United States

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

Ninewells Hospital - Endocrinology

Dundee, United Kingdom

RECRUITING

FutureMeds Glasgow

Glasgow, United Kingdom

RECRUITING

University of Liverpool - Aintree University Hospital

Liverpool, United Kingdom

RECRUITING

St Pancras Clinical Research

London, United Kingdom

RECRUITING

Manchester Diabetes Centre (MDC)

Manchester, United Kingdom

RECRUITING

George Eliot Hospital NHS Trust

Nuneaton, United Kingdom

RECRUITING

Royal Hallamshire Hospital - Endocrinology

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 18, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); DE (3); GB (9); IT (2); CA (4); US (25)