Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

NCT ID: NCT06696443

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2027-01-25

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Detailed Description

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Conditions

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Diabetic Peripheral Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suzetrigine (SUZ)

Participants will receive SUZ once daily (qd) up to 52 weeks.

Group Type EXPERIMENTAL

Suzetrigine

Intervention Type DRUG

Tablets for oral administration.

Interventions

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Suzetrigine

Tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-548 SUZ

Eligibility Criteria

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Inclusion Criteria

• Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Exclusion Criteria

* Any sensory abnormality (excluding DPN)
* History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
* Current participation in an investigational drug trial (other than a parent study)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pinnacle Research Group, LLC

Anniston, Alabama, United States

Site Status

AMR Daphne, AL

Daphne, Alabama, United States

Site Status

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Long Beach Research Institute

Long Beach, California, United States

Site Status

Angel City Research, Inc

Los Angeles, California, United States

Site Status

Empire Clinical Research

Pomona, California, United States

Site Status

Clinical Trials Research

Sacramento, California, United States

Site Status

Velocity Clinical Research, San Bernardino

San Bernardino, California, United States

Site Status

SCLA Management - Pain Management and Injury Relief

Thousand Oaks, California, United States

Site Status

Velocity Clinical Research - Denver

Englewood, Colorado, United States

Site Status

Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia, United States

Site Status

AMR-Miami

Coral Gables, Florida, United States

Site Status

Accel Research - Deland

DeLand, Florida, United States

Site Status

Suncoast Research Associates - Miami

Doral, Florida, United States

Site Status

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida, United States

Site Status

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, United States

Site Status

CNS Healthcare - Jacksonville

Jacksonville, Florida, United States

Site Status

Accel Research Site - St. Petersburg/Largo

Largo, Florida, United States

Site Status

Accel Research Sites - Maitland

Maitland, Florida, United States

Site Status

3Sync Research - Miami Lakes

Miami Lakes, Florida, United States

Site Status

Suncoast Clinical Research - New Port Richey

New Port Richey, Florida, United States

Site Status

Conquest Clinical Research - Orlando - Neuro

Orlando, Florida, United States

Site Status

Conquest Clinical Research - Winter Park

Winter Park, Florida, United States

Site Status

Accel Research - Decatur

Decatur, Georgia, United States

Site Status

Velocity Clinical Research - Boise

Meridian, Idaho, United States

Site Status

Feinberg School of Medicine - Anesthesiology

Chicago, Illinois, United States

Site Status

Healthcare Research Network - Flossmoor IL

Tinley Park, Illinois, United States

Site Status

Synexus Clinical Research - Evansville

Evansville, Indiana, United States

Site Status

AMR Wichita East, KS (Heartland Research Associates)

Wichita, Kansas, United States

Site Status

AMR Lexington

Lexington, Kentucky, United States

Site Status

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, United States

Site Status

Tandem Clinical Research- Covington

Covington, Louisiana, United States

Site Status

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

Boston, Massachusetts, United States

Site Status

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri, United States

Site Status

AMR Kansas City

Kansas City, Missouri, United States

Site Status

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, United States

Site Status

HRI - Hassman Research Institute

Marlton, New Jersey, United States

Site Status

Velocity Clinical Research - Albuquerque

Albuquerque, New Mexico, United States

Site Status

Swift Clinical OpCo, Inc

Brooklyn, New York, United States

Site Status

Velocity Clinical Research - Syracuse

East Syracuse, New York, United States

Site Status

Synexus Clinical Research - New York (DRS)

New York, New York, United States

Site Status

Columbia Presbyterian - The Neurological Institute of New York

New York, New York, United States

Site Status

West Clinical Research

Morehead City, North Carolina, United States

Site Status

Eximia Research - Raleigh

Raleigh, North Carolina, United States

Site Status

Carolinas Pain Institute - Winston-Salem Office

Winston-Salem, North Carolina, United States

Site Status

Velocity Clinical Research - Cleveland

Beachwood, Ohio, United States

Site Status

Synexus Clinical Research - Cincinnati

Cincinnati, Ohio, United States

Site Status

META Medical Research Institute

Dayton, Ohio, United States

Site Status

Velocity Clinical Research - Medford

Medford, Oregon, United States

Site Status

Suburban Research Associates - Media

Media, Pennsylvania, United States

Site Status

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, United States

Site Status

Synexus Clinical Research- Anderson

Anderson, South Carolina, United States

Site Status

Clinical Trials of South Carolina - Charleston

Charleston, South Carolina, United States

Site Status

M3 Wake Research - Charleston

Charleston, South Carolina, United States

Site Status

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Zenos Clinical Research

Dallas, Texas, United States

Site Status

Be Well Clinical Studies - Austin

Round Rock, Texas, United States

Site Status

San Antonio Clinical Trials

San Antonio, Texas, United States

Site Status

Velocity Clinical Research - Waco

Waco, Texas, United States

Site Status

Kalo Clinical Research - Salt Lake City

Salt Lake City, Utah, United States

Site Status

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, United States

Site Status

Dominion Medical Associates, Inc.

Richmond, Virginia, United States

Site Status

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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VX24-548-112

Identifier Type: -

Identifier Source: org_study_id

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