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

Last updated: January 27, 2026
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Not Recruiting

Phase

3

Condition

Pain (Pediatric)

Pain

Neurologic Disorders

Treatment

Suzetrigine

Clinical Study ID

NCT06696443
VX24-548-112
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

• 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

Exclusion

Key Exclusion Criteria:

  • Any sensory abnormality (excluding DPN)

  • History of drug intolerance in a parent study that would pose an additional risk tothe 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.

Study Design

Total Participants: 455
Treatment Group(s): 1
Primary Treatment: Suzetrigine
Phase: 3
Study Start date:
December 18, 2024
Estimated Completion Date:
January 25, 2027

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • AMR Daphne, AL

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Pinnacle Research Group, LLC

    Anniston 4830198, Alabama 4829764 36207
    United States

    Site Not Available

  • AMR Daphne, AL

    Daphne 4058219, Alabama 4829764 36526
    United States

    Site Not Available

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Scottsdale Clinical Trials

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

    Site Not Available

  • Angel City Research, Inc

    Los Angeles, California 90010
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona, California 91767
    United States

    Site Not Available

  • Clinical Trials Research

    Sacramento, California 95821
    United States

    Site Not Available

  • Velocity Clinical Research, San Bernardino

    San Bernardino, California 92408
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno 5350937, California 5332921 93710
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach 5367929, California 5332921 90805
    United States

    Site Not Available

  • Angel City Research, Inc

    Los Angeles 5368361, California 5332921 90010
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona 5384170, California 5332921 91767
    United States

    Site Not Available

  • Clinical Trials Research

    Sacramento 5389489, California 5332921 95821
    United States

    Site Not Available

  • Velocity Clinical Research, San Bernardino

    San Bernardino 5391710, California 5332921 92408
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Site Not Available

  • SCLA Management - Pain Management and Injury Relief

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Site Not Available

  • Velocity Clinical Research - Denver

    Englewood 5421250, Colorado 5417618 80110
    United States

    Site Not Available

  • Velocity Clinical Research - Washington DC

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Velocity Clinical Research - Washington DC

    Washington D.C. 4140963, District of Columbia 4138106 20016
    United States

    Site Not Available

  • AMR-Miami

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Accel Research Site - Deland Clinical Research Unit

    DeLand, Florida 32720
    United States

    Site Not Available

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Accel Research Site - St. Petersburg/Largo

    Largo, Florida 33777
    United States

    Site Not Available

  • Accel Research Sites - Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • Suncoast Research Associates - Miami

    Miami, Florida 33173
    United States

    Site Not Available

  • 3Sync Research - Miami Lakes

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Suncoast Clinical Research - New Port Richey

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Conquest Research Orlando Neuro

    Orlando, Florida 32832
    United States

    Site Not Available

  • Conquest Research Winter Park

    Winter Park, Florida 32789
    United States

    Site Not Available

  • AMR-Miami

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Accel Research - Deland

    DeLand 4152890, Florida 4155751 32720
    United States

    Site Not Available

  • Accel Research Site - Deland Clinical Research Unit

    DeLand 4152890, Florida 4155751 32720
    United States

    Site Not Available

  • Suncoast Research Associates - Miami

    Doral 4153471, Florida 4155751 33172
    United States

    Site Not Available

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach

    Hallandale 4157898, Florida 4155751 33009
    United States

    Site Not Available

  • CNS Healthcare - Jacksonville

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Accel Research Site - St. Petersburg/Largo

    Largo 4161580, Florida 4155751 33777
    United States

    Site Not Available

  • Accel Research Sites - Maitland

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • 3Sync Research - Miami Lakes

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Suncoast Clinical Research - New Port Richey

    New Port Richey 4165869, Florida 4155751 34652
    United States

    Site Not Available

  • Conquest Clinical Research - Orlando - Neuro

    Orlando 4167147, Florida 4155751 32832
    United States

    Site Not Available

  • Conquest Research Orlando Neuro

    Orlando 4167147, Florida 4155751 32832
    United States

    Site Not Available

  • Conquest Clinical Research - Winter Park

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Conquest Research Winter Park

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • ARSN - NeuroStudies

    Decatur, Georgia 30030
    United States

    Site Not Available

  • ARSN - NeuroStudies

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Accel Research - Decatur

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Velocity Clinical Research - Boise (Advanced Clinical Research)

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Velocity Clinical Research - Boise

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Velocity Clinical Research - Boise (Advanced Clinical Research)

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Feinberg School of Medicine

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Feinberg School of Medicine - Anesthesiology

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Healthcare Research Network II, LLC

    Flossmoor 4892684, Illinois 4896861 60422
    United States

    Site Not Available

  • Healthcare Research Network - Flossmoor IL

    Tinley Park 4913723, Illinois 4896861 604773027
    United States

    Site Not Available

  • Synexus Clinical Research - Evansville

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Synexus Clinical Research - Evansville

    Evansville 4257227, Indiana 4921868 47714
    United States

    Site Not Available

  • AMR Wichita East, KS

    Wichita, Kansas 67207
    United States

    Site Not Available

  • AMR Wichita East, KS

    Wichita 4281730, Kansas 4273857 67207
    United States

    Site Not Available

  • AMR Wichita East, KS (Heartland Research Associates)

    Wichita 4281730, Kansas 4273857 67207
    United States

    Site Not Available

  • AMR Lexington

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • AMR Lexington

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Site Not Available

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Tandem Clinical Research- Covington

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge 4315588, Louisiana 4331987 70809
    United States

    Site Not Available

  • Tandem Clinical Research- Covington

    Covington 4321005, Louisiana 4331987 70433
    United States

    Site Not Available

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Brigham and Women's Hospital (BWH)

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

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

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham 4954380, Massachusetts 6254926 02451
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • AMR Kansas City

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood 4389967, Missouri 4398678 63042
    United States

    Site Not Available

  • Healthcare Research Network - Hazelwood MO

    Hazelwood 4389967, Missouri 4398678 63042
    United States

    Site Not Available

  • AMR Kansas City

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Site Not Available

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Velocity Clinical Research - Norfolk

    Norfolk 5073965, Nebraska 5073708 68701
    United States

    Site Not Available

  • Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • HRI - Hassman Research Institute

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Hassman Research Institute

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • Velocity Clinical Research - Albuquerque

    Albuquerque 5454711, New Mexico 5481136 87107
    United States

    Site Not Available

  • Swift Clinical OpCo, Inc

    Brooklyn, New York 11226
    United States

    Site Not Available

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Synexus Clinical Research- New York

    New York, New York 10017
    United States

    Site Not Available

  • Swift Clinical OpCo, Inc

    Brooklyn 5110302, New York 5128638 11226
    United States

    Site Not Available

  • Velocity Clinical Research - Syracuse

    East Syracuse 5116079, New York 5128638 13057
    United States

    Site Not Available

  • Columbia Presbyterian - The Neurological Institute of New York

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Synexus Clinical Research - New York (DRS)

    New York 5128581, New York 5128638 10017
    United States

    Site Not Available

  • Synexus Clinical Research- New York

    New York 5128581, New York 5128638 10017
    United States

    Site Not Available

  • West Clinical Research

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Eximia Research - Raleigh

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • West Clinical Research

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Eximia Research - Raleigh

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Carolinas Pain Institute - Winston-Salem Office

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Synexus Clinical Research US - Cincinnati

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Velocity Clinical Research - Cleveland

    Beachwood 5146711, Ohio 5165418 44122
    United States

    Site Not Available

  • Synexus Clinical Research - Cincinnati

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Site Not Available

  • Synexus Clinical Research US - Cincinnati

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Site Not Available

  • META Medical Research Institute

    Dayton 4509884, Ohio 5165418 45432
    United States

    Site Not Available

  • Velocity Clinical Research - Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Velocity Clinical Research - Medford

    Medford 5740099, Oregon 5744337 97504
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Suburban Research Associates

    Media 4559575, Pennsylvania 6254927 19063
    United States

    Site Not Available

  • Suburban Research Associates - Media

    Media 4559575, Pennsylvania 6254927 19063
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • Synexus Clinical Research- Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Synexus Clinical Research- Anderson

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Site Not Available

  • Clinical Trials of South Carolina - Charleston

    Charleston 4574324, South Carolina 4597040 29406
    United States

    Site Not Available

  • M3 Wake Research - Charleston

    Charleston 4574324, South Carolina 4597040 29414
    United States

    Site Not Available

  • Velocity Clinical Research - Spartanburg

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Be Well Clinical Studies - Austin

    Round Rock, Texas 78681
    United States

    Site Not Available

  • San Antonio Clinical Trials

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Velocity Clinical Research - Waco

    Waco, Texas 76710
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Be Well Clinical Studies - Austin

    Round Rock 4724129, Texas 4736286 78681
    United States

    Site Not Available

  • San Antonio Clinical Trials

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

  • Velocity Clinical Research - Waco

    Waco 4739526, Texas 4736286 76710
    United States

    Site Not Available

  • Kalo Clinical Research

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Kalo Clinical Research

    Salt Lake City 5780993, Utah 5549030 84102
    United States

    Site Not Available

  • Kalo Clinical Research - Salt Lake City

    Salt Lake City 5780993, Utah 5549030 84102
    United States

    Site Not Available

  • Velocity Clinical Research - Salt Lake City

    West Jordan 5784549, Utah 5549030 84088
    United States

    Site Not Available

  • Dominion Medical Associates, Inc.

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Dominion Medical Associates, Inc.

    Richmond 4781708, Virginia 6254928 23219
    United States

    Site Not Available

  • Northwest Clinical Research Center (NWCRC)

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Northwest Clinical Research Center (NWCRC)

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

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