Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated · NCT06628908
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 1100
- US sites recruiting
- 58
- Study start
- October 1, 2024
- Record last updated
- October 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Suzetrigine; Placebo (matched to SUZ); Pregabalin; Placebo (matched to Pregabalin)
Conditions: Diabetic Peripheral Neuropathic Pain
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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 limited variation in the 7-day Baseline Period
Key Exclusion Criteria
- 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.
Recruiting US locations
Pinnacle Research Group, LLC
Anniston, AL 36207
Scottsdale Clinical Trials
Scottsdale, AZ 85260
Neuro-Pain Medical Center
Fresno, CA 93710
Long Beach Research Institute
Long Beach, CA 90805
Angel City Research, Inc
Los Angeles, CA 90010
Empire Clinical Research
Pomona, CA 91767
Clinical Trials Research
Sacramento, CA 95821
Velocity Clinical Research, San Bernardino
San Bernardino, CA 92408
SCLA Management - Pain Management and Injury Relief
Thousand Oaks, CA 91320
Velocity Clinical Research - Denver
Englewood, CO 80110
Velocity Clinical Research - Washington DC
Washington D.C., DC 20016
Accel Research - Deland
DeLand, FL 32720
AMR-Miami
Doral, FL 33172
AMR Fort Myers (The Clinical Study Center)
Fort Myers, FL 33912
Velocity Clinical Research - Hallandale Beach
Hallandale, FL 33009
CNS Healthcare - Jacksonville
Jacksonville, FL 32256
Accel Research - St. Petersburg-Largo
Largo, FL 33777
Suncoast Research Associates - Miami
Miami, FL 33172
3Sync Research - Miami Lakes
Miami Lakes, FL 33014
Suncoast Clinical Research - New Port Richey
New Port Richey, FL 34652
Conquest Clinical Research - Orlando - Neuro
Orlando, FL 32832
Conquest Clinical Research - Winter Park
Winter Park, FL 32789
Accel Research - Decatur
Decatur, GA 30030
Velocity Clinical Research - Boise
Meridian, ID 83642
Feinberg School of Medicine - Anesthesiology
Chicago, IL 60611
Healthcare Research Network - Flossmoor IL
Flossmoor, IL 604773027
AMR Wichita East, KS (Heartland Research Associates)
Wichita, KS 67207
AMR Lexington
Lexington, KY 40509
Velocity Clinical Research - Baton Rouge
Baton Rouge, LA 70809
Tandem Clinical Research- Covington
Covington, LA 70433
Mass General Brigham - Brigham and Women's Hospital - Main Campus
Boston, MA 02115
MedVadis Research Corporation
Waltham, MA 02451
Healthcare Research Network - Hazelwood MO
Hazelwood, MO 63042
AMR Kansas City
Kansas City, MO 64114
Velocity Clinical Research - Norfolk
Norfolk, NE 68701
Velocity Clinical Research - Albuquerque
Albuquerque, NM 87107
Swift Clinical OpCo, Inc
Brooklyn, NY 11226
Velocity Clinical Research - Syracuse
East Syracuse, NY 13057
Columbia Presbyterian - The Neurological Institute of New York
New York, NY 10032
West Clinical Research
Morehead City, NC 28557
Eximia Research - Raleigh
Raleigh, NC 27607
Carolinas Pain Institute - Winston-Salem Office
Winston-Salem, NC 27103
Velocity Clinical Research - Cleveland
Beachwood, OH 44122
META Medical Research Institute
Dayton, OH 45432
Velocity Clinical Research - Medford
Medford, OR 97504
Suburban Research Associates - Media
Media, PA 19063
Velocity Clinical Research - Providence
East Greenwich, RI 02818
Clinical Trials of South Carolina - Berkeley - Charleston
Charleston, SC 29406
M3 Wake Research - Charleston
Charleston, SC 29414
Velocity Clinical Research - Spartanburg
Spartanburg, SC 29303
Zenos Clinical Research
Dallas, TX 75230
Be Well Clinical Studies - Austin
Round Rock, TX 78681
San Antonio Clinical Trials
San Antonio, TX 78240
Velocity Clinical Research - Waco
Waco, TX 76710
Velocity Clinical Research - Salt Lake City
West Jordan, UT 84088
Kalo Clinical Research - West Valley City
West Valley City, UT 84120
Dominion Medical Associates, Inc.
Richmond, VA 23219
Northwest Clinical Research Center (NWCRC)
Bellevue, WA 98007
Study contacts (from the official record)
- Medical Information · 617-341-6777 · medicalinfo@vrtx.com
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