Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Drug: Placebo (matched to SUZ)Drug: Placebo (matched to Pregabalin)
- Registration Number
- NCT06628908
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- 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
- More than 3 missing daily NPRS scores during the 7-day Baseline Period
- Participation in a previous study in which the participant received SUZ
- Any sensory abnormality (excluding DPN) as pre-specified in the protocol
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suzetrigine (SUZ) Placebo (matched to Pregabalin) Participants will be randomized to receive SUZ. Pregabalin Placebo (matched to SUZ) Participants will be randomized to receive Pregabalin. Pregabalin Pregabalin Participants will be randomized to receive Pregabalin. Placebo Placebo (matched to SUZ) Participants will be randomized to receive placebo matched to SUZ and Pregabalin. Placebo Placebo (matched to Pregabalin) Participants will be randomized to receive placebo matched to SUZ and Pregabalin. Suzetrigine (SUZ) Suzetrigine Participants will be randomized to receive SUZ.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo From Baseline up to Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin (pooled with data from Study VX24-548-111) From Baseline up to Week 12 Change From Baseline in 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111) From Baseline up to Week 12
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (75)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Synexus Clinical Research US - Birmingham
🇺🇸Birmingham, Alabama, United States
AMR Daphne, AL
🇺🇸Daphne, Alabama, United States
Synexus Clinical Research US - Phoenix Central
🇺🇸Phoenix, Arizona, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Velocity Clinical Research, San Bernardino
🇺🇸San Bernardino, California, United States
Pain Management and Injury Relief
🇺🇸Thousand Oaks, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Velocity Clinical Research - Denver
🇺🇸Englewood, Colorado, United States
Velocity Clinical Research - Washington DC
🇺🇸Washington, District of Columbia, United States
AMR-Miami
🇺🇸Coral Gables, Florida, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Angel City Research, Inc
🇺🇸Los Angeles, California, United States
Accel Research Site - Deland Clinical Research Unit
🇺🇸DeLand, Florida, United States
AMR Fort Myers (The Clinical Study Center)
🇺🇸Fort Myers, Florida, United States
Velocity Clinical Research - Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Accel Research Site - St. Petersburg/Largo
🇺🇸Largo, Florida, United States
Accel Research Sites - Maitland
🇺🇸Maitland, Florida, United States
3Sync Research - Miami Lakes
🇺🇸Miami Lakes, Florida, United States
Suncoast Research Associates - Miami
🇺🇸Miami, Florida, United States
Suncoast Clinical Research - New Port Richey
🇺🇸New Port Richey, Florida, United States
Synexus Clinical Research US - Orlando
🇺🇸Orlando, Florida, United States
Conquest Research Orlando Neuro
🇺🇸Orlando, Florida, United States
Conquest Research Winter Park
🇺🇸Winter Park, Florida, United States
ARSN - NeuroStudies
🇺🇸Decatur, Georgia, United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
🇺🇸Meridian, Idaho, United States
Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Synexus Clinical Research - Evansville
🇺🇸Evansville, Indiana, United States
AMR Wichita East, KS
🇺🇸Wichita, Kansas, United States
AMR Lexington
🇺🇸Lexington, Kentucky, United States
Velocity Clinical Research - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Tandem Clinical Research- Covington
🇺🇸Covington, Louisiana, United States
Brigham and Women's Hospital (BWH)
🇺🇸Boston, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
AMR Kansas City
🇺🇸Kansas City, Missouri, United States
Synexus Clinical Research US - St. Louis
🇺🇸Saint Louis, Missouri, United States
Velocity Clinical Research - Norfolk
🇺🇸Norfolk, Nebraska, United States
Synexus Clinical Research - Henderson
🇺🇸Las Vegas, Nevada, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
Velocity Clinical Research - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Swift Clinical OpCo, Inc
🇺🇸Brooklyn, New York, United States
Velocity Clinical Research - Syracuse
🇺🇸East Syracuse, New York, United States
Synexus Clinical Research- New York
🇺🇸New York, New York, United States
The Neurological Institute of New York
🇺🇸New York, New York, United States
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
Eximia Research - Raleigh
🇺🇸Raleigh, North Carolina, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Velocity Clinical Research - Cleveland
🇺🇸Beachwood, Ohio, United States
Synexus Clinical Research US - Cincinnati
🇺🇸Cincinnati, Ohio, United States
META Medical Research Institute
🇺🇸Dayton, Ohio, United States
Velocity Clinical Research - Grants Pass
🇺🇸Grants Pass, Oregon, United States
Velocity Clinical Research - Medford
🇺🇸Medford, Oregon, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, 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
Charleston Clinical Trials, LLC
🇺🇸Charleston, South Carolina, United States
Velocity Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
AMR Nashville, TN
🇺🇸Nashville, Tennessee, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Synexus - Dallas
🇺🇸Dallas, Texas, United States
San Antonio Clinical Trials
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research - Waco
🇺🇸Waco, Texas, United States
Be Well Clinical Studies - Austin
🇺🇸Round Rock, Texas, United States
Velocity Clinical Research - Salt Lake City
🇺🇸West Jordan, Utah, United States
Kalo Clinical Research
🇺🇸West Valley City, Utah, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center (NWCRC)
🇺🇸Bellevue, Washington, United States