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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07231419
Phase
PHASE3
Status
Recruiting

Conditions

  • Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    Tablets for oral administration
  • Placebo (matched to SUZ) — DRUG
    Placebo matched to SUZ for oral administration.

Study Details

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

Key Dates

Start date
Nov 21, 2025
Status verified
Nov 2025
Primary completion
Apr 6, 2027
Completion
Apr 6, 2027

Study Design

Enrollment
734 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suzetrigine (SUZ)
    Participants will be randomized to receive SUZ.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive placebo matched to SUZ.

Primary Outcome Measure

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo [ Time Frame: From Baseline up to Week 12 ]

Central Contacts

Locations (75)

FacilityCityStateZIPSite coordinators
Accel Research - BirminghamBirminghamAlabama35216-
Central Research Associates, LLCBirminghamAlabama35205-
AMR MobileMobileAlabama36608-
Sun City Clinical ResearchGlendaleArizona85304-
Scottsdale Clinical TrialsScottsdaleArizona85260-
Lynn Institute of the OzarksLittle RockArkansas72204-
Hope Clinical ResearchCanoga ParkCalifornia91303-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Eximia Research-CA, LLCLa MesaCalifornia91942-
Long Beach Research InstituteLong BeachCalifornia90805-
Paradigm Clincial Research - ModestoModestoCalifornia95355-
Pasadena Clinical TrialsPasadenaCalifornia91101-
Artemis Institute for Clinical Research - RiversideRiversideCalifornia92503-
Velocity Clinical Research -San BernardinoSan BernardinoCalifornia92408-
Alpine Clinical Research CenterBoulderColorado80301-
Paradigm Clinical Research - Wheat RidgeWheat RidgeColorado80033-
Chase Medical ResearchWaterburyConnecticut06708-
Velocity Clinical Research - Washington DCWashington D.C.District of Columbia20016-
Neurology Offices of South Florida, PLLCBoca RatonFlorida33428-
Accel Research - DelandDeLandFlorida32720-
Velocity Clinical Research - Hallandale BeachHallandaleFlorida33009-
CNS Healthcare - JacksonvilleJacksonvilleFlorida32256-
Health Awareness, Inc. - JupiterJupiterFlorida33458-
3Sync Research -Miami LakesMiami LakesFlorida33014-
Aqualane Clinical ResearchNaplesFlorida34105-
CNS Healthcare - OrlandoOrlandoFlorida32806-
Suncoast Clinical Research - Palm HarborPalm HarborFlorida34684-
3Sync Research - Palm SpringsPalm SpringsFlorida33461-
Health Awareness, Inc. - Port St. LuciePort Saint LucieFlorida34952-
ClinCloud - VieraVieraFlorida32940-
Conquest Clinical Research - Winter ParkWinter ParkFlorida32789-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Accel Research - DecaturDecaturGeorgia30030-
Javara Inc./Privia Medical Group - Fayetteville, GAFayettevilleGeorgia30214-
Velocity Clinical Research - SavannahSavannahGeorgia31406-
Healthcare Research Network - Flossmoor ILTinley ParkIllinois60477-
Velocity Clinical Research - Baton RougeBaton RougeLouisiana70809-
Velocity Clinical Research - LafayetteLafayetteLouisiana70508-
Velocity Clinical Research - RockvilleRockvilleMaryland20854-
Boston Clinical TrialsBostonMassachusetts02131-
Quest Research InstituteFarmington HillsMichigan48334-
Velocity Clinical Research - GulfportGulfportMississippi39503-
SCLA Management - St. Louis Pain ConsultantsCreve CoeurMissouri63141-
Healthcare Research Network - Hazelwood MOHazelwoodMissouri63042-
AMR Kansas CityKansas CityMissouri64114-
M3 Wake Research - Las VegasLas VegasNevada89106-
CenExel AMRIToms RiverNew Jersey08755-
Brooklyn Clinical ResearchBrooklynNew York11226-
Velocity Clinical Research - SyracuseEast SyracuseNew York13057-
Mid Hudson Medical Research, PLLCNew WindsorNew York12553-
Rochester Clinical Research - RochesterRochesterNew York14609-
Asheville Clinical ResearchAshevilleNorth Carolina28803-
Monroe Biomedical researchMonroeNorth Carolina28112-
West Clinical ResearchMorehead CityNorth Carolina28557-
Velocity Clinical Research - ClevelandBeachwoodOhio44122-
Velocity Clinical Research - Cincinnati - Blue AshCincinnatiOhio45242-
Lynn Institute of NormanNormanOklahoma73072-
Velocity Clinical Research - MedfordMedfordOregon97504-
Velocity Clinical Research - ProvidenceEast GreenwichRhode Island02818-
Velocity Clinical Research - AndersonAndersonSouth Carolina29621-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Velocity Clinical Research - SpartanburgSpartanburgSouth Carolina29303-
M3 Wake Research - ChattanoogaChattanoogaTennessee37421-
Holston Medical GroupKingsportTennessee37660-
AMR Knoxville, TNKnoxvilleTennessee37909-
CNS Healthcare - MemphisMemphisTennessee38119-
Amarillo Medical Specialists LLPAmarilloTexas79124-
QCR - BioBehavioral Research of AustinAustinTexas78759-
Zenos Clinical ResearchDallasTexas75230-
Fort Worth Endocrine Research CenterFort WorthTexas76132-
Epic Clinical ResearchLewisvilleTexas75057-
Prime Clinical Research - Mansfield - US 287MansfieldTexas76063-
Clinical Trials of Texas, LLCSan AntonioTexas78229-
AMR NorfolkNorfolkVirginia23502-
Velocity Clinical Research - SpokaneSpokaneWashington99218-

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