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

Last updated: May 23, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Enrolling

Phase

3

Condition

Pain (Pediatric)

Neurologic Disorders

Pain

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: 300
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

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 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

  • Velocity Clinical Research - Washington DC

    Washington, District of Columbia 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 33137
    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

  • ARSN - NeuroStudies

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Velocity Clinical Research - Boise (Advanced Clinical Research)

    Meridian, Idaho 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

  • AMR Wichita East, KS

    Wichita, Kansas 67207
    United States

    Site Not Available

  • AMR Lexington

    Lexington, Kentucky 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

  • MedVadis Research Corporation

    Waltham, Massachusetts 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

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico 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

  • 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

  • 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 - Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 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

  • 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

  • Kalo Clinical Research

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Dominion Medical Associates, Inc.

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Northwest Clinical Research Center (NWCRC)

    Bellevue, Washington 98007
    United States

    Site Not Available

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