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NCT06628908PHASE3Recruiting

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

Vertex Pharmaceuticals Incorporated

Start Date

10/1/2024

Completion Date

5/31/2027

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 Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Suzetrigine

DRUG

Placebo (matched to SUZ)

DRUG

Pregabalin

DRUG

Placebo (matched to Pregabalin)

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Conditions

Diabetic Peripheral Neuropathic Pain

Locations

Pinnacle Research Group, LLC

Anniston, Alabama 36207

United States

Synexus Clinical Research - Birmingham

Birmingham, Alabama 35211

United States

AMR Daphne, AL

Daphne, Alabama 36526

United States

Synexus Clinical Research - Phoenix Central

Phoenix, Arizona 85020

United States

Scottsdale Clinical Trials

Scottsdale, Arizona 85260

United States

Neuro-Pain Medical Center

Fresno, California 93710

United States

Long Beach Research Institute

Long Beach, California 90805

United States

Angel City Research, Inc

Los Angeles, California 90010

United States

Empire Clinical Research

Pomona, California 91767

United States

Clinical Trials Research

Sacramento, California 95821

United States

Velocity Clinical Research, San Bernardino

San Bernardino, California 92408

United States

SCLA Management - Pain Management and Injury Relief

Thousand Oaks, California 91320

United States

Diablo Clinical Research (DCR)

Walnut Creek, California 94598

United States

Velocity Clinical Research - Denver

Englewood, Colorado 80110

United States

Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia 20016

United States

Accel Research - Deland

DeLand, Florida 32720

United States

AMR-Miami

Doral, Florida 33172

United States

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida 33912

United States

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida 33009

United States

CNS Healthcare - Jacksonville

Jacksonville, Florida 32256

United States

Accel Research - St. Petersburg-Largo

Largo, Florida 33777

United States

Accel Research - Maitland

Maitland, Florida 32751

United States

Suncoast Research Associates - Miami

Miami, Florida 33172

United States

3Sync Research - Miami Lakes

Miami Lakes, Florida 33014

United States

Suncoast Clinical Research - New Port Richey

New Port Richey, Florida 34652

United States

Synexus Clinical Research - Orlando

Orlando, Florida 32806

United States

Conquest Clinical Research - Orlando - Neuro

Orlando, Florida 32832

United States

Conquest Clinical Research - Winter Park

Winter Park, Florida 32789

United States

Accel Research - Decatur

Decatur, Georgia 30030

United States

Velocity Clinical Research - Boise

Meridian, Idaho 83642

United States

Feinberg School of Medicine - Anesthesiology

Chicago, Illinois 60611

United States

Healthcare Research Network - Flossmoor IL

Flossmoor, Illinois 604773027

United States

Synexus Clinical Research - Evansville

Evansville, Indiana 47714

United States

AMR Wichita East, KS (Heartland Research Associates)

Wichita, Kansas 67207

United States

AMR Lexington

Lexington, Kentucky 40509

United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana 70809

United States

Tandem Clinical Research- Covington

Covington, Louisiana 70433

United States

Mass General Brigham - Brigham and Women's Hospital - Main Campus

Boston, Massachusetts 02115

United States

MedVadis Research Corporation

Waltham, Massachusetts 02451

United States

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri 63042

United States

AMR Kansas City

Kansas City, Missouri 64114

United States

St. Louis Children's Hospital - Nephrology

St Louis, Missouri 63110

United States

Synexus Clinical Research - St. Louis

St Louis, Missouri 63141

United States

Velocity Clinical Research - Norfolk

Norfolk, Nebraska 68701

United States

Synexus Clinical Research - Las Vegas

Las Vegas, Nevada 89113

United States

HRI - Hassman Research Institute

Marlton, New Jersey 08053

United States

Velocity Clinical Research - Albuquerque

Albuquerque, New Mexico 87107

United States

Albany Medical College

Albany, New York 12208

United States

Swift Clinical OpCo, Inc

Brooklyn, New York 11226

United States

Velocity Clinical Research - Syracuse

East Syracuse, New York 13057

United States

Synexus Clinical Research - New York (DRS)

New York, New York 10017

United States

Columbia Presbyterian - The Neurological Institute of New York

New York, New York 10032

United States

West Clinical Research

Morehead City, North Carolina 28557

United States

Eximia Research - Raleigh

Raleigh, North Carolina 27607

United States

Carolinas Pain Institute - Winston-Salem Office

Winston-Salem, North Carolina 27103

United States

Velocity Clinical Research - Cleveland

Beachwood, Ohio 44122

United States

Synexus Clinical Research - Cincinnati

Cincinnati, Ohio 45236

United States

META Medical Research Institute

Dayton, Ohio 45432

United States

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon 97527

United States

Velocity Clinical Research - Medford

Medford, Oregon 97504

United States

Suburban Research Associates - Media

Media, Pennsylvania 19063

United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island 02818

United States

Synexus Clinical Research- Anderson

Anderson, South Carolina 29621

United States

Clinical Trials of South Carolina - Berkeley - Charleston

Charleston, South Carolina 29406

United States

M3 Wake Research - Charleston

Charleston, South Carolina 29414

United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina 29303

United States

AMR Nashville, TN

Nashville, Tennessee 37203

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

Synexus Clinical Research - Dallas (DFW) (DRS)

Dallas, Texas 75234

United States

Be Well Clinical Studies - Austin

Round Rock, Texas 78681

United States

San Antonio Clinical Trials

San Antonio, Texas 78240

United States

Velocity Clinical Research - Waco

Waco, Texas 76710

United States

Velocity Clinical Research - Salt Lake City

West Jordan, Utah 84088

United States

Kalo Clinical Research - West Valley City

West Valley City, Utah 84120

United States

Dominion Medical Associates, Inc.

Richmond, Virginia 23219

United States

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington 98007

United States