Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

Last updated: April 9, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Pain

Pain (Pediatric)

Neurologic Disorders

Treatment

Placebo (matched to Pregabalin)

Pregabalin

Suzetrigine

Clinical Study ID

NCT06628908
VX24-548-110
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Body weight greater than or equal to (≥) 45 kilogram (kg)

  • Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)

  • Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN

  • Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limitedvariation in the 7-day Baseline Period

Exclusion

Key Exclusion Criteria:

  • More than 3 missing daily NPRS scores during the 7-day Baseline Period

  • Participation in a previous study in which the participant received SUZ

  • Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 1100
Treatment Group(s): 4
Primary Treatment: Placebo (matched to Pregabalin)
Phase: 3
Study Start date:
October 01, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Synexus Clinical Research US - Birmingham

    Birmingham, Alabama 35211
    United States

    Active - Recruiting

  • AMR Daphne, AL

    Daphne, Alabama 36526
    United States

    Active - Recruiting

  • Synexus Clinical Research US - Phoenix Central

    Phoenix, Arizona 85020
    United States

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  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

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  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

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  • Long Beach Research Institute

    Long Beach, California 90805
    United States

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  • Angel City Research, Inc

    Los Angeles, California 90010
    United States

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  • Empire Clinical Research

    Pomona, California 91767
    United States

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  • Clinical Trials Research

    Sacramento, California 95821
    United States

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  • Velocity Clinical Research - Banning

    San Bernardino, California 92408
    United States

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  • Velocity Clinical Research, San Bernardino

    San Bernardino, California 92408
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  • Pain Management and Injury Relief

    Thousand Oaks, California 91320
    United States

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    Walnut Creek, California 94598
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    Englewood, Colorado 80110
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    Washington, District of Columbia 20016
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    Coral Gables, Florida 33134
    United States

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    DeLand, Florida 32720
    United States

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    Fort Myers, Florida 33912
    United States

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    Hallandale Beach, Florida 33009
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    Jacksonville, Florida 32256
    United States

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    Largo, Florida 33777
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    Maitland, Florida 32751
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    Miami, Florida 33137
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    Miami, Florida 33137
    United States

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    Miami Lakes, Florida 33014
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    New Port Richey, Florida 34652
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    Orlando, Florida 32832
    United States

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    Orlando, Florida 32806
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    Winter Park, Florida 32789
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    Decatur, Georgia 30030
    United States

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    Meridian, Idaho 83642
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    Chicago, Illinois 60611
    United States

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    Flossmoor, Illinois 60422
    United States

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    Evansville, Indiana 47714
    United States

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    Wichita, Kansas 67207
    United States

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    Lexington, Kentucky 40509
    United States

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    Baton Rouge, Louisiana 70809
    United States

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    Covington, Louisiana 70433
    United States

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    Boston, Massachusetts 02115
    United States

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    Waltham, Massachusetts 02451
    United States

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    Hazelwood, Missouri 63042
    United States

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    Kansas City, Missouri 64114
    United States

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    Saint Louis, Missouri 63141
    United States

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    Norfolk, Nebraska 68701
    United States

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    Las Vegas, Nevada 89113
    United States

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    Marlton, New Jersey 08053
    United States

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    Albuquerque, New Mexico 87107
    United States

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    Albany, New York 12208
    United States

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  • Swift Clinical OpCo, Inc

    Brooklyn, New York 11226
    United States

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    East Syracuse, New York 13057
    United States

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    New York, New York 10017
    United States

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  • The Neurological Institute of New York

    New York, New York 10032
    United States

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  • West Clinical Research

    Morehead City, North Carolina 28557
    United States

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  • Eximia Clinical Research - NC

    Raleigh, North Carolina 27607
    United States

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  • Eximia Research - Raleigh

    Raleigh, North Carolina 27607
    United States

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  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103
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    Beachwood, Ohio 44122
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    Cincinnati, Ohio 45236
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  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

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    Grants Pass, Oregon 97527
    United States

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    Medford, Oregon 97504
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  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

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    East Greenwich, Rhode Island 02818
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    Anderson, South Carolina 29621
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    Charleston, South Carolina 29406
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    Spartanburg, South Carolina 29303
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    Nashville, Tennessee 37203
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    Dallas, Texas 75234
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    Dallas, Texas 75230
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    Round Rock, Texas 78681
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    Waco, Texas 76710
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    West Jordan, Utah 84088
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    West Valley City, Utah 84120
    United States

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  • Dominion Medical Associates, Inc.

    Richmond, Virginia 23219
    United States

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  • Northwest Clinical Research Center (NWCRC)

    Bellevue, Washington 98007
    United States

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