Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- Registration Number
- NCT05660538
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
-
Diagnosis of diabetes mellitus type 1 or type 2 with
- Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
- Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Key
- Painful neuropathy other than DPN
- 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
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VX-548 VX-548 Participants will be randomized to receive different dose levels of VX-548. VX-548 Placebo (matched to pregabalin) Participants will be randomized to receive different dose levels of VX-548. Pregabalin Placebo (matched to VX-548) Participants will receive pregabalin. Pregabalin Pregabalin Participants will receive pregabalin.
- Primary Outcome Measures
Name Time Method Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Baseline, Week 12 Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment At Week 12 Proportions of Participants With Greater Than or Equal to (≥) 30 Percent (%), ≥50%, and ≥70% Reductions from Baseline in the Weekly Average of Daily Pain Intensity on the NPRS Baseline, Week 12 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Week 14
Trial Locations
- Locations (50)
University Clinical Investigators
🇺🇸Tustin, California, United States
Velocity Clinical Research - Medford
🇺🇸Medford, Oregon, United States
Synexus - Orlando
🇺🇸Orlando, Florida, United States
Velocity Clinical Research - Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Synexus - The Villages
🇺🇸The Villages, Florida, United States
Synexus Clinical Research - Evansville
🇺🇸Evansville, Indiana, United States
Synexus Clinical Research - Henderson
🇺🇸Henderson, Nevada, United States
Accel Research Sites - Maitland
🇺🇸Maitland, Florida, United States
Boston PainCare Center
🇺🇸Waltham, Massachusetts, United States
Synexus Clinical Research- New York
🇺🇸New York, New York, United States
Synexus Clinical Research- Anderson
🇺🇸Anderson, South Carolina, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Accel Research Sites - Neurostudies
🇺🇸Decatur, Georgia, United States
AMR Kansas City
🇺🇸Kansas City, Missouri, United States
Boston Neuro Research Center, LLC
🇺🇸North Dartmouth, Massachusetts, United States
Healthcare Research Network - Hazelwood
🇺🇸Hazelwood, Missouri, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
AMR Newton
🇺🇸Newton, Kansas, United States
Accel Research Sites - Tampa
🇺🇸Largo, Florida, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Clinical Trials of America, LLC
🇺🇸Monroe, Louisiana, United States
Healthcare Research Network - Chicago
🇺🇸Flossmoor, Illinois, United States
AMR El Dorado
🇺🇸El Dorado, Kansas, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Synexus Clinical Research US - St. Louis
🇺🇸Saint Louis, Missouri, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
Clinical Trials of South Carolina - Charleston
🇺🇸Charleston, South Carolina, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Northwest Clinical Research Center (NWCRC)
🇺🇸Bellevue, Washington, United States
Synexus - Dallas
🇺🇸Dallas, Texas, United States
Long Beach Clinical Trials Services, Inc.
🇺🇸Long Beach, California, United States
AMR Fort Myers (The Clinical Study Center)
🇺🇸Fort Myers, Florida, United States
Velocity Clinical Research - Banning
🇺🇸Banning, California, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Velocity Clinical Research - Cleveland
🇺🇸Cleveland, Ohio, United States
Suncoast Research Associates
🇺🇸Miami, Florida, United States
Brigham and Women's Hospital (BWH) - Translational Pain Research
🇺🇸Boston, Massachusetts, United States
Synexus - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Diabetes & Glandular Disease Clinic, P.A
🇺🇸San Antonio, Texas, United States
Synexus Clinical Research US - Birmingham
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research US - Phoenix West
🇺🇸Phoenix, Arizona, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
🇺🇸Meridian, Idaho, United States
Revival Research Institute
🇺🇸Dearborn, Michigan, United States
AMR Wichita East, KS
🇺🇸Wichita, Kansas, United States
South Carolina Clinical Research
🇺🇸Orangeburg, South Carolina, United States