Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
NCT ID: NCT05660538
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2022-12-20
2023-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pregabalin
Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks
Pregabalin
Capsules for oral administration.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
Suzetrigine
Tablets for oral administration.
Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
Suzetrigine
Tablets for oral administration.
Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
Suzetrigine
Tablets for oral administration.
Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Interventions
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Suzetrigine
Tablets for oral administration.
Pregabalin
Capsules for oral administration.
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
* Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Exclusion Criteria
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
18 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Synexus Clinical Research US - Birmingham
Birmingham, Alabama, United States
Synexus Clinical Research US - Phoenix West
Phoenix, Arizona, United States
Velocity Clinical Research - Banning
Banning, California, United States
Long Beach Clinical Trials Services, Inc.
Long Beach, California, United States
University Clinical Investigators
Tustin, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Accel Research Sites - Tampa
Largo, Florida, United States
Accel Research Sites - Maitland
Maitland, Florida, United States
Suncoast Research Associates
Miami, Florida, United States
Synexus - Orlando
Orlando, Florida, United States
Synexus - The Villages
The Villages, Florida, United States
Accel Research Sites - Neurostudies
Decatur, Georgia, United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho, United States
Healthcare Research Network - Chicago
Flossmoor, Illinois, United States
Synexus Clinical Research - Evansville
Evansville, Indiana, United States
AMR El Dorado
El Dorado, Kansas, United States
AMR Newton
Newton, Kansas, United States
AMR Wichita East, KS
Wichita, Kansas, United States
Clinical Trials of America, LLC
Monroe, Louisiana, United States
Brigham and Women's Hospital (BWH) - Translational Pain Research
Boston, Massachusetts, United States
Boston Neuro Research Center, LLC
North Dartmouth, Massachusetts, United States
Boston PainCare Center
Waltham, Massachusetts, United States
Revival Research Institute
Dearborn, Michigan, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, United States
AMR Kansas City
Kansas City, Missouri, United States
Synexus Clinical Research US - St. Louis
St Louis, Missouri, United States
Synexus Clinical Research - Henderson
Henderson, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Synexus Clinical Research- New York
New York, New York, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Synexus - Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research - Cleveland
Cleveland, Ohio, United States
Velocity Clinical Research - Medford
Medford, Oregon, 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
South Carolina Clinical Research
Orangeburg, South Carolina, United States
Inquest Clinical Research
Baytown, Texas, United States
Synexus - Dallas
Dallas, Texas, United States
Diabetes & Glandular Disease Clinic, P.A
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Northwest Clinical Research Center (NWCRC)
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX21-548-103
Identifier Type: -
Identifier Source: org_study_id
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