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Diabetic Peripheral Neuropathic PainPhase 3NCT06696443

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

A Phase 3 study testing Suzetrigine in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 65 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Peripheral Neuropathic Pain
What is being tested?
Suzetrigine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
455 participants
Where
65 sitesUnited States
Study dates
18 Dec 2024to 25 Jan 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Who cannot join

  • Any sensory abnormality (excluding DPN)
  • History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
  • Current participation in an investigational drug trial (other than a parent study)
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87107

  • Synexus Clinical Research- Anderson

    Anderson, South Carolina, 29621

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio, 44122

  • Northwest Clinical Research Center (NWCRC)

    Bellevue, Washington, 98007

  • Mass General Brigham - Brigham and Women's Hospital - Main Campus

    Boston, Massachusetts, 02115

  • Swift Clinical OpCo, Inc

    Brooklyn, New York, 11226

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina, 29406

  • M3 Wake Research - Charleston

    Charleston, South Carolina, 29414

  • Feinberg School of Medicine - Anesthesiology

    Chicago, Illinois, 60611

  • Synexus Clinical Research - Cincinnati

    Cincinnati, Ohio, 45236

  • AMR-Miami

    Coral Gables, Florida, 33134

  • Tandem Clinical Research- Covington

    Covington, Louisiana, 70433

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • AMR Daphne, AL

    Daphne, Alabama, 36526

  • META Medical Research Institute

    Dayton, Ohio, 45432

  • Accel Research - Decatur

    Decatur, Georgia, 30030

  • Accel Research - Deland

    DeLand, Florida, 32720

  • Suncoast Research Associates - Miami

    Doral, Florida, 33172

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • Velocity Clinical Research - Denver

    Englewood, Colorado, 80110

  • Synexus Clinical Research - Evansville

    Evansville, Indiana, 47714

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers, Florida, 33912

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida, 33009

  • Healthcare Research Network - Hazelwood MO

    Hazelwood, Missouri, 63042

  • CNS Healthcare - Jacksonville

    Jacksonville, Florida, 32256

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • Accel Research Site - St. Petersburg/Largo

    Largo, Florida, 33777

  • AMR Lexington

    Lexington, Kentucky, 40509

  • Long Beach Research Institute

    Long Beach, California, 90805

  • Angel City Research, Inc

    Los Angeles, California, 90010

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751

  • HRI - Hassman Research Institute

    Marlton, New Jersey, 08053

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • Suburban Research Associates - Media

    Media, Pennsylvania, 19063

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • 3Sync Research - Miami Lakes

    Miami Lakes, Florida, 33014

  • West Clinical Research

    Morehead City, North Carolina, 28557

  • Suncoast Clinical Research - New Port Richey

    New Port Richey, Florida, 34652

  • Synexus Clinical Research - New York (DRS)

    New York, New York, 10017

  • Columbia Presbyterian - The Neurological Institute of New York

    New York, New York, 10032

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska, 68701

  • Conquest Clinical Research - Orlando - Neuro

    Orlando, Florida, 32832

  • Empire Clinical Research

    Pomona, California, 91767

  • Eximia Research - Raleigh

    Raleigh, North Carolina, 27607

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Be Well Clinical Studies - Austin

    Round Rock, Texas, 78681

  • Clinical Trials Research

    Sacramento, California, 95821

  • Kalo Clinical Research - Salt Lake City

    Salt Lake City, Utah, 84102

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240

  • Velocity Clinical Research, San Bernardino

    San Bernardino, California, 92408

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29303

  • SCLA Management - Pain Management and Injury Relief

    Thousand Oaks, California, 91320

  • Healthcare Research Network - Flossmoor IL

    Tinley Park, Illinois, 604773027

  • Velocity Clinical Research - Waco

    Waco, Texas, 76710

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Velocity Clinical Research - Washington DC

    Washington D.C., District of Columbia, 20016

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84088

  • AMR Wichita East, KS (Heartland Research Associates)

    Wichita, Kansas, 67207

  • Carolinas Pain Institute - Winston-Salem Office

    Winston-Salem, North Carolina, 27103

  • Conquest Clinical Research - Winter Park

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Being tested
Suzetrigine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SuzetrigineDrug

    Also called VX-548, SUZ

    Tablets for oral administration.

Study groups in NCT06696443
Study groupRoleWhat they receive
Suzetrigine (SUZ)ExperimentalParticipants will receive SUZ once daily (qd) up to 52 weeks.
Receives: Drug: Suzetrigine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Baseline up to Week 54

Secondary outcomes (2)

  1. Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score

    Measured: From Baseline up to Week 52

  2. Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score

    Measured: From Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start18 Dec 2024
  3. Primary completion25 Jan 2027 (estimated)
  4. Study completion25 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696443
Sponsor's protocol ID
VX24-548-112
Status last verified
Oct 2026
First submitted
15 Nov 2024
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Publications

  • Siddiqui A, Xu JL, Abramowicz AE. Suzetrigine for the Treatment of Acute Pain: Comment. Anesthesiology. 2026 Feb 1;144(2):495-496. doi: 10.1097/ALN.0000000000005822. Epub 2025 Dec 11. No abstract available.

    PubMed 41384808

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