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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Vertex Pharmaceuticals Incorporated
Where
Albany, Albuquerque, Anderson, Anniston, Baton Rouge, Beachwood, Bellevue, Birmingham, Boston, Brooklyn, Charleston, Chicago, Cincinnati, Covington, Dallas, Daphne, Dayton, Decatur, DeLand, Doral, East Greenwich, East Syracuse, Englewood, Evansville, Flossmoor, Fort Myers, Fresno, Grants Pass, Hallandale, Hazelwood, Jacksonville, Kansas City, Largo, Las Vegas, Lexington, Long Beach, Los Angeles, Maitland, Marlton, Medford, Media, Meridian, Miami, Miami Lakes, Morehead City, Nashville, New Port Richey, New York, Norfolk, Orlando, Phoenix, Pomona, Raleigh, Richmond, Round Rock, Sacramento, San Antonio, San Bernardino, Scottsdale, Spartanburg, St Louis, Thousand Oaks, Waco, Walnut Creek, Waltham, Washington D.C., West Jordan, West Valley City, Wichita, Winston-Salem, and Winter Park, United StatesSee the 76 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
1,100 people, planned
Started
1 Oct 2024
Expected to end
31 May 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Suzetrigine
  • Placebo (matched to SUZ)
  • Pregabalin
  • Placebo (matched to Pregabalin)
Record updated
15 October 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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 limited variation in the 7-day Baseline Period

Who cannot take part

  • More than 3 missing daily NPRS scores during the 7-day Baseline Period
  • Any sensory abnormality (excluding DPN) as pre-specified in the protocol; Other protocol defined Inclusion/Exclusion criteria may apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • Albany Medical CollegeAlbany, United StatesNo longer taking part
  • Velocity Clinical Research - AlbuquerqueAlbuquerque, United StatesTaking people
  • Synexus Clinical Research- AndersonAnderson, United StatesNo longer taking part
  • Pinnacle Research Group, LLCAnniston, United StatesTaking people
  • Velocity Clinical Research - Baton RougeBaton Rouge, United StatesTaking people
  • Velocity Clinical Research, ClevelandBeachwood, United StatesTaking people
  • Northwest Clinical Research Center (NWCRC)Bellevue, United StatesTaking people
  • Synexus Clinical Research - BirminghamBirmingham, United StatesNo longer taking part
  • Mass General Brigham - Brigham and Women's Hospital - Main CampusBoston, United StatesTaking people
  • Swift Clinical OpCo, IncBrooklyn, United StatesTaking people
  • Clinical Trials of South Carolina - Berkeley - CharlestonCharleston, United StatesTaking people
  • M3 Wake Research - CharlestonCharleston, United StatesTaking people
  • Feinberg School of Medicine - AnesthesiologyChicago, United StatesTaking people
  • Synexus Clinical Research - CincinnatiCincinnati, United StatesNo longer taking part
  • Tandem Clinical Research- CovingtonCovington, United StatesTaking people
  • Zenos Clinical ResearchDallas, United StatesTaking people
  • Synexus Clinical Research - Dallas (DFW) (DRS)Dallas, United StatesNo longer taking part
  • AMR Daphne, ALDaphne, United StatesNo longer taking part
  • META Medical Research InstituteDayton, United StatesTaking people
  • Accel Research - DecaturDecatur, United StatesTaking people
  • Accel Research - DelandDeLand, United StatesTaking people
  • AMR-MiamiDoral, United StatesTaking people
  • Velocity Clinical Research, ProvidenceEast Greenwich, United StatesTaking people
  • Velocity Clinical Research, SyracuseEast Syracuse, United StatesTaking people
  • Velocity Clinical Research, DenverEnglewood, United StatesTaking people
  • Synexus Clinical Research - EvansvilleEvansville, United StatesNo longer taking part
  • Healthcare Research Network - Flossmoor ILFlossmoor, United StatesTaking people
  • AMR Fort Myers (The Clinical Study Center)Fort Myers, United StatesTaking people
  • Neuro-Pain Medical CenterFresno, United StatesTaking people
  • Velocity Clinical Research, Grants PassGrants Pass, United StatesNo longer taking part
  • Velocity Clinical Research, Hallandale BeachHallandale, United StatesTaking people
  • Healthcare Research Network - Hazelwood MOHazelwood, United StatesTaking people
  • CNS Healthcare - JacksonvilleJacksonville, United StatesTaking people
  • AMR Kansas CityKansas City, United StatesTaking people
  • Accel Research - St. Petersburg-LargoLargo, United StatesTaking people
  • Synexus Clinical Research - Las VegasLas Vegas, United StatesNo longer taking part
  • AMR LexingtonLexington, United StatesTaking people
  • Long Beach Research InstituteLong Beach, United StatesTaking people
  • Angel City Research, Inc.Los Angeles, United StatesTaking people
  • Accel Research - MaitlandMaitland, United StatesNo longer taking part
  • HRI - Hassman Research InstituteMarlton, United StatesNo longer taking part
  • Velocity Clinical Research, MedfordMedford, United StatesTaking people
  • Suburban Research Associates - MediaMedia, United StatesTaking people
  • Velocity Clinical Research, BoiseMeridian, United StatesTaking people
  • Suncoast Research Associates - MiamiMiami, United StatesTaking people
  • 3Sync Research - Miami LakesMiami Lakes, United StatesTaking people
  • West Clinical ResearchMorehead City, United StatesTaking people
  • AMR Nashville, TNNashville, United StatesNo longer taking part
  • Suncoast Clinical Research - New Port RicheyNew Port Richey, United StatesTaking people
  • Columbia Presbyterian - The Neurological Institute of New YorkNew York, United StatesTaking people
  • Synexus Clinical Research - New York (DRS)New York, United StatesNo longer taking part
  • Velocity Clinical Research - NorfolkNorfolk, United StatesTaking people
  • Conquest Clinical Research - Orlando - NeuroOrlando, United StatesTaking people
  • Synexus Clinical Research - OrlandoOrlando, United StatesNo longer taking part
  • Synexus Clinical Research - Phoenix CentralPhoenix, United StatesNo longer taking part
  • Empire Clinical ResearchPomona, United StatesTaking people
  • Eximia Research - RaleighRaleigh, United StatesTaking people
  • Dominion Medical Associates, Inc.Richmond, United StatesTaking people
  • Be Well Clinical Studies - AustinRound Rock, United StatesTaking people
  • Clinical Trials ResearchSacramento, United StatesTaking people
  • San Antonio Clinical TrialsSan Antonio, United StatesTaking people
  • Velocity Clinical Research, San BernardinoSan Bernardino, United StatesTaking people
  • Scottsdale Clinical TrialsScottsdale, United StatesTaking people
  • Velocity Clinical Research, SpartanburgSpartanburg, United StatesTaking people
  • St. Louis Children's Hospital - NephrologySt Louis, United StatesNo longer taking part
  • Synexus Clinical Research - St. LouisSt Louis, United StatesNo longer taking part
  • SCLA Management - Pain Management and Injury ReliefThousand Oaks, United StatesTaking people
  • Velocity Clinical Research, WacoWaco, United StatesTaking people
  • Diablo Clinical Research (DCR)Walnut Creek, United StatesNo longer taking part
  • MedVadis Research CorporationWaltham, United StatesTaking people
  • Velocity Clinical Research, Washington DCWashington D.C., United StatesTaking people
  • Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesTaking people
  • Kalo Clinical Research - West Valley CityWest Valley City, United StatesTaking people
  • AMR Wichita East, KS (Heartland Research Associates)Wichita, United StatesTaking people
  • Carolinas Pain Institute - Winston-Salem OfficeWinston-Salem, United StatesTaking people
  • Conquest Clinical Research (Winter Park)Winter Park, United StatesTaking people

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Suzetrigine (SUZ)Treatment being tested

    Participants will be randomized to receive SUZ.

    Treatment: Suzetrigine and Placebo (matched to Pregabalin)

  • PregabalinExisting treatment, for comparison

    Participants will be randomized to receive Pregabalin.

    Treatment: Placebo (matched to SUZ) and Pregabalin

  • PlaceboPlacebo, for comparison

    Participants will be randomized to receive placebo matched to SUZ and Pregabalin.

    Treatment: Placebo (matched to SUZ) and Placebo (matched to Pregabalin)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Fit questions
Built from NCT06628908, who can take part
Publications
Record updated
15 October 2026