A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Body weight greater than or equal to (≥)45 kilogram (kg)
• Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2)
• Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year
• Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
Locations
United States
Alabama
Accel Research - Birmingham
RECRUITING
Birmingham
AMR Mobile
RECRUITING
Mobile
Arizona
Scottsdale Clinical Trials
RECRUITING
Scottsdale
California
Hope Clinical Research
RECRUITING
Canoga Park
Marvel Clinical Research
RECRUITING
Huntington Beach
Eximia Research-CA, LLC
RECRUITING
La Mesa
Long Beach Research Institute
RECRUITING
Long Beach
Paradigm Clincial Research - Modesto
RECRUITING
Modesto
Pasadena Clinical Trials
RECRUITING
Pasadena
Velocity Clinical Research -San Bernardino
RECRUITING
San Bernardino
Colorado
Alpine Clinical Research Center
RECRUITING
Boulder
Paradigm Clinical Research - Wheat Ridge
RECRUITING
Wheat Ridge
Washington, D.c.
Velocity Clinical Research - Washington DC
RECRUITING
Washington D.c.
Florida
Neurology Offices of South Florida, PLLC
RECRUITING
Boca Raton
Accel Research - Deland
RECRUITING
Deland
Velocity Clinical Research - Hallandale Beach
RECRUITING
Hallandale
CNS Healthcare - Jacksonville
RECRUITING
Jacksonville
Health Awareness, Inc. - Jupiter
RECRUITING
Jupiter
3Sync Research -Miami Lakes
RECRUITING
Miami Lakes
CNS Healthcare - Orlando
RECRUITING
Orlando
3Sync Research - Palm Springs
RECRUITING
Palm Springs
Health Awareness, Inc. - Port St. Lucie
RECRUITING
Port Saint Lucie
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Accel Research - Decatur
RECRUITING
Decatur
Javara Inc./Privia Medical Group - Fayetteville, GA
RECRUITING
Fayetteville
Velocity Clinical Research - Savannah
RECRUITING
Savannah
Illinois
Healthcare Research Network - Flossmoor IL
RECRUITING
Tinley Park
Louisiana
Velocity Clinical Research - Baton Rouge
RECRUITING
Baton Rouge
Velocity Clinical Research - Lafayette
RECRUITING
Lafayette
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
Missouri
Healthcare Research Network - Hazelwood MO
RECRUITING
Hazelwood
AMR Kansas City
RECRUITING
Kansas City
Mississippi
Velocity Clinical Research - Gulfport
RECRUITING
Gulfport
North Carolina
Asheville Clinical Research
RECRUITING
Asheville
West Clinical Research
RECRUITING
Morehead City
New Jersey
CenExel AMRI
RECRUITING
Toms River
Nevada
M3 Wake Research - Las Vegas
RECRUITING
Las Vegas
New York
Brooklyn Clinical Research
RECRUITING
Brooklyn
Velocity Clinical Research - Syracuse
RECRUITING
East Syracuse
Mid Hudson Medical Research, PLLC
RECRUITING
New Windsor
Rochester Clinical Research - Rochester
RECRUITING
Rochester
Ohio
Velocity Clinical Research - Cleveland
RECRUITING
Beachwood
Velocity Clinical Research - Cincinnati - Blue Ash
RECRUITING
Cincinnati
Oregon
Velocity Clinical Research - Medford
RECRUITING
Medford
Rhode Island
Velocity Clinical Research - Providence
RECRUITING
East Greenwich
South Carolina
Velocity Clinical Research - Anderson
RECRUITING
Anderson
Velocity Clinical Research - Spartanburg
RECRUITING
Spartanburg
Tennessee
AMR Knoxville, TN
RECRUITING
Knoxville
CNS Healthcare - Memphis
RECRUITING
Memphis
Texas
Amarillo Medical Specialists LLP
RECRUITING
Amarillo
QCR - BioBehavioral Research of Austin
RECRUITING
Austin
Zenos Clinical Research
RECRUITING
Dallas
Fort Worth Endocrine Research Center
RECRUITING
Fort Worth
Epic Clinical Research
RECRUITING
Lewisville
Virginia
AMR Norfolk
RECRUITING
Norfolk
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
6173416777
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2027-04-06
Participants
Target number of participants: 734
Treatments
Experimental: Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Placebo_comparator: Placebo
Participants will be randomized to receive placebo matched to SUZ.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated