Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
- Registration Number
- NCT06696443
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
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
A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 300
• 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
Key
- 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)
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Suzetrigine (SUZ) Suzetrigine Participants will receive SUZ once daily (qd) up to 52 weeks.
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline up to Week 54
- Secondary Outcome Measures
Name Time Method Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score From Baseline up to Week 52 Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score From Baseline up to Week 52
Trial Locations
- Locations (53)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
3Sync Research - Miami Lakes
🇺🇸Miami Lakes, Florida, United States
Conquest Research Winter Park
🇺🇸Winter Park, Florida, United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
🇺🇸Meridian, Idaho, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
Velocity Clinical Research - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Velocity Clinical Research - Syracuse
🇺🇸East Syracuse, New York, United States
Synexus Clinical Research- New York
🇺🇸New York, New York, United States
Pain Management and Injury Relief
🇺🇸Thousand Oaks, California, United States
Velocity Clinical Research - Washington DC
🇺🇸Washington, District of Columbia, United States
AMR-Miami
🇺🇸Coral Gables, Florida, United States
Accel Research Site - St. Petersburg/Largo
🇺🇸Largo, Florida, United States
Suncoast Research Associates - Miami
🇺🇸Miami, Florida, United States
Suncoast Clinical Research - New Port Richey
🇺🇸New Port Richey, Florida, United States
Conquest Research Orlando Neuro
🇺🇸Orlando, Florida, United States
ARSN - NeuroStudies
🇺🇸Decatur, Georgia, United States
AMR Kansas City
🇺🇸Kansas City, Missouri, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Accel Research Site - Deland Clinical Research Unit
🇺🇸DeLand, Florida, United States
Velocity Clinical Research - Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
AMR Wichita East, KS
🇺🇸Wichita, Kansas, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Swift Clinical OpCo, Inc
🇺🇸Brooklyn, New York, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Synexus Clinical Research US - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Velocity Clinical Research - Norfolk
🇺🇸Norfolk, Nebraska, United States
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
Eximia Research - Raleigh
🇺🇸Raleigh, North Carolina, United States
AMR Daphne, AL
🇺🇸Daphne, Alabama, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Accel Research Sites - Maitland
🇺🇸Maitland, Florida, United States
Velocity Clinical Research - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Tandem Clinical Research- Covington
🇺🇸Covington, Louisiana, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Velocity Clinical Research - Cleveland
🇺🇸Beachwood, Ohio, United States
Velocity Clinical Research - Medford
🇺🇸Medford, Oregon, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Velocity Clinical Research, San Bernardino
🇺🇸San Bernardino, California, United States
AMR Fort Myers (The Clinical Study Center)
🇺🇸Fort Myers, Florida, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Synexus Clinical Research- Anderson
🇺🇸Anderson, South Carolina, United States
Clinical Trials of South Carolina - Charleston
🇺🇸Charleston, South Carolina, United States
Velocity Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Be Well Clinical Studies - Austin
🇺🇸Round Rock, Texas, United States
San Antonio Clinical Trials
🇺🇸San Antonio, Texas, United States
Kalo Clinical Research
🇺🇸Salt Lake City, Utah, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center (NWCRC)
🇺🇸Bellevue, Washington, United States