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New pill could ease diabetic nerve pain in landmark trial

NCT ID NCT06619860

Symptom relief Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 2 trial tests an experimental oral drug called VX-993 for pain caused by diabetic peripheral neuropathy, a common complication of diabetes. About 300 adults with type 1 or type 2 diabetes and nerve pain in both legs for at least a year will receive VX-993, pregabalin (a standard treatment), or placebo for 12 weeks. The main goal is to see if VX-993 reduces daily pain intensity more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VX-993 (oral tablet)
What this could lead to
If successful, VX-993 could offer a new option for managing chronic nerve pain in people with diabetes, potentially with fewer side effects than current treatments.
What could go wrong
This is an early Phase 2 trial with only 300 participants. The drug may not reduce pain better than existing treatments or placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathic pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMR Fort Myers (The Clinical Study Center)

    COMPLETED

    Fort Myers, Florida, 33912, United States

  • AMR Norfolk

    COMPLETED

    Norfolk, Virginia, 23502, United States

  • Accel Research - Decatur

    COMPLETED

    Decatur, Georgia, 30030, United States

  • Accel Research - Deland

    COMPLETED

    DeLand, Florida, 32720, United States

  • Altasciences - Beaumont Clinic Montreal

    RECRUITING

    Montreal, Canada

  • Atlanta Center for Medical Research

    COMPLETED

    Atlanta, Georgia, 30331, United States

  • Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU

    RECRUITING

    Birmingham, United Kingdom

  • CHU de Nîmes - Pain Assessment and Treatment Center

    RECRUITING

    Nîmes, France

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied

    RECRUITING

    Clermont-Ferrand, France

  • Centricity Research Brampton

    RECRUITING

    Brampton, Canada

  • Clinical Trials of South Carolina - Berkeley - Moncks Corner

    COMPLETED

    Moncks Corner, South Carolina, 29461, United States

  • Cullman Clinical Trials

    COMPLETED

    Cullman, Alabama, 35055, United States

  • Eximia Research - Raleigh

    COMPLETED

    Raleigh, North Carolina, 27607, United States

  • Eximia Research - San Diego

    COMPLETED

    La Mesa, California, 91942, United States

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, Italy

  • FutureMeds Birmingham

    RECRUITING

    Birmingham, United Kingdom

  • FutureMeds Frankfurt

    RECRUITING

    Offenbach/Main, Germany

  • FutureMeds Glasgow

    RECRUITING

    Glasgow, United Kingdom

  • FutureMeds GmbH

    RECRUITING

    Berlin, Germany

  • Gadolin Research

    COMPLETED

    Beaumont, Texas, 77702, United States

  • George Eliot Hospital NHS Trust

    RECRUITING

    Nuneaton, United Kingdom

  • Health Awareness, Inc. - Port St. Lucie

    COMPLETED

    Port Saint Lucie, Florida, 34952, United States

  • Health Awareness, Inc., Jupiter

    COMPLETED

    Jupiter, Florida, 33458, United States

  • Healthcare Research Network - Flossmoor IL

    COMPLETED

    Flossmoor, Illinois, 604773027, United States

  • Healthcare Research Network - Hazelwood MO

    COMPLETED

    Hazelwood, Missouri, 63042, United States

  • Hopital Cochin - Rheumatology

    RECRUITING

    Paris, France

  • IRCCS Ospedale San Raffaele - InSpe and Division of Neuroscience

    RECRUITING

    Milan, Italy

  • Innovation Medical Research Center - Palmetto

    COMPLETED

    Palmetto Bay, Florida, 33157, United States

  • Manchester Diabetes Centre (MDC)

    RECRUITING

    Manchester, United Kingdom

  • Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)

    RECRUITING

    Toronto, Canada

  • Ninewells Hospital - Endocrinology

    RECRUITING

    Dundee, United Kingdom

  • North Hospital

    RECRUITING

    Saint-Priest-en-Jarez, France

  • OCT Research ULC

    RECRUITING

    Kelowna, Canada

  • Paradigm Clincial Research Centers, LLC., Wheat Ridge

    COMPLETED

    Wheat Ridge, Colorado, 80033, United States

  • Quest Research Institute

    COMPLETED

    Farmington Hills, Michigan, 48334, United States

  • Royal Hallamshire Hospital - Endocrinology

    RECRUITING

    Sheffield, United Kingdom

  • Ruhr-Universitaet Bochum - Heart and Diabetes Center

    RECRUITING

    Bad Oeynhausen, Germany

  • San Antonio Clinical Trials

    COMPLETED

    San Antonio, Texas, 78240, United States

  • St Pancras Clinical Research

    RECRUITING

    London, United Kingdom

  • Suncoast Research Associates - Miami

    COMPLETED

    Miami, Florida, 33172, United States

  • Trovare Clinical Research - Bakersfield CA

    COMPLETED

    Bakersfield, California, 93301, United States

  • University of Liverpool - Aintree University Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Velocity Clinical Research - Boise

    COMPLETED

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Cleveland

    COMPLETED

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research - Hallandale Beach

    COMPLETED

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research - Providence

    COMPLETED

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research, Dallas

    COMPLETED

    Dallas, Texas, 75230, United States

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