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
Status: Recruiting
Location: See all (76) 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 (SUZ) 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) ≥18.0 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
Locations
United States
Alabama
Pinnacle Research Group, LLC
RECRUITING
Anniston
Synexus Clinical Research - Birmingham
COMPLETED
Birmingham
AMR Daphne, AL
COMPLETED
Daphne
Arizona
Synexus Clinical Research - Phoenix Central
COMPLETED
Phoenix
Scottsdale Clinical Trials
RECRUITING
Scottsdale
California
Neuro-Pain Medical Center
RECRUITING
Fresno
Long Beach Research Institute
RECRUITING
Long Beach
Angel City Research, Inc
RECRUITING
Los Angeles
Empire Clinical Research
RECRUITING
Pomona
Clinical Trials Research
RECRUITING
Sacramento
Velocity Clinical Research, San Bernardino
RECRUITING
San Bernardino
SCLA Management - Pain Management and Injury Relief
RECRUITING
Thousand Oaks
Diablo Clinical Research (DCR)
RECRUITING
Walnut Creek
Colorado
Velocity Clinical Research - Denver
RECRUITING
Englewood
Washington, D.c.
Velocity Clinical Research - Washington DC
RECRUITING
Washington D.c.
Florida
Accel Research - Deland
RECRUITING
Deland
AMR-Miami
RECRUITING
Doral
AMR Fort Myers (The Clinical Study Center)
RECRUITING
Fort Myers
Velocity Clinical Research - Hallandale Beach
RECRUITING
Hallandale
CNS Healthcare - Jacksonville
RECRUITING
Jacksonville
Accel Research - St. Petersburg-Largo
RECRUITING
Largo
Accel Research - Maitland
RECRUITING
Maitland
Suncoast Research Associates - Miami
RECRUITING
Miami
3Sync Research - Miami Lakes
RECRUITING
Miami Lakes
Suncoast Clinical Research - New Port Richey
RECRUITING
New Port Richey
Conquest Clinical Research - Orlando - Neuro
RECRUITING
Orlando
Synexus Clinical Research - Orlando
COMPLETED
Orlando
Conquest Clinical Research - Winter Park
RECRUITING
Winter Park
Georgia
Accel Research - Decatur
RECRUITING
Decatur
Idaho
Velocity Clinical Research - Boise
RECRUITING
Meridian
Illinois
Feinberg School of Medicine - Anesthesiology
RECRUITING
Chicago
Healthcare Research Network - Flossmoor IL
RECRUITING
Flossmoor
Indiana
Synexus Clinical Research - Evansville
RECRUITING
Evansville
Kansas
AMR Wichita East, KS (Heartland Research Associates)
RECRUITING
Wichita
Kentucky
AMR Lexington
RECRUITING
Lexington
Louisiana
Velocity Clinical Research - Baton Rouge
RECRUITING
Baton Rouge
Tandem Clinical Research- Covington
RECRUITING
Covington
Massachusetts
Mass General Brigham - Brigham and Women's Hospital - Main Campus
RECRUITING
Boston
MedVadis Research Corporation
RECRUITING
Waltham
Missouri
Healthcare Research Network - Hazelwood MO
RECRUITING
Hazelwood
AMR Kansas City
RECRUITING
Kansas City
St. Louis Children's Hospital - Nephrology
RECRUITING
St Louis
Synexus Clinical Research - St. Louis
COMPLETED
St Louis
North Carolina
West Clinical Research
RECRUITING
Morehead City
Eximia Research - Raleigh
RECRUITING
Raleigh
Carolinas Pain Institute - Winston-Salem Office
RECRUITING
Winston-salem
Nebraska
Velocity Clinical Research - Norfolk
RECRUITING
Norfolk
New Jersey
HRI - Hassman Research Institute
RECRUITING
Marlton
New Mexico
Velocity Clinical Research - Albuquerque
RECRUITING
Albuquerque
Nevada
Synexus Clinical Research - Las Vegas
COMPLETED
Las Vegas
New York
Albany Medical College
RECRUITING
Albany
Swift Clinical OpCo, Inc
RECRUITING
Brooklyn
Velocity Clinical Research - Syracuse
RECRUITING
East Syracuse
Columbia Presbyterian - The Neurological Institute of New York
RECRUITING
New York
Synexus Clinical Research - New York (DRS)
COMPLETED
New York
Ohio
Velocity Clinical Research - Cleveland
RECRUITING
Beachwood
Synexus Clinical Research - Cincinnati
COMPLETED
Cincinnati
META Medical Research Institute
RECRUITING
Dayton
Oregon
Velocity Clinical Research - Grants Pass
COMPLETED
Grants Pass
Velocity Clinical Research - Medford
RECRUITING
Medford
Pennsylvania
Suburban Research Associates - Media
RECRUITING
Media
Rhode Island
Velocity Clinical Research - Providence
RECRUITING
East Greenwich
South Carolina
Synexus Clinical Research- Anderson
COMPLETED
Anderson
Clinical Trials of South Carolina - Berkeley - Charleston
RECRUITING
Charleston
M3 Wake Research - Charleston
RECRUITING
Charleston
Velocity Clinical Research - Spartanburg
RECRUITING
Spartanburg
Tennessee
AMR Nashville, TN
COMPLETED
Nashville
Texas
Synexus Clinical Research - Dallas (DFW) (DRS)
COMPLETED
Dallas
Zenos Clinical Research
RECRUITING
Dallas
Be Well Clinical Studies - Austin
RECRUITING
Round Rock
San Antonio Clinical Trials
RECRUITING
San Antonio
Velocity Clinical Research - Waco
RECRUITING
Waco
Utah
Velocity Clinical Research - Salt Lake City
RECRUITING
West Jordan
Kalo Clinical Research - West Valley City
RECRUITING
West Valley City
Virginia
Dominion Medical Associates, Inc.
RECRUITING
Richmond
Washington
Northwest Clinical Research Center (NWCRC)
RECRUITING
Bellevue
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 1100
Treatments
Experimental: Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Active_comparator: Pregabalin
Participants will be randomized to receive Pregabalin.
Placebo_comparator: Placebo
Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated