Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Registration Number
- NCT06619860
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
-
Diagnosis of diabetes mellitus type 1 or type 2 with
- Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
- Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) 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-993 VX-993 Participants will be randomized to receive multiple doses of different dose levels of VX-993. VX-993 Placebo (matched to pregabalin) Participants will be randomized to receive multiple doses of different dose levels of VX-993. Pregabalin Placebo (matched to VX-993) Participants will be randomized to receive Pregabalin. Pregabalin Pregabalin Participants will be randomized to receive Pregabalin.
- 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 From Baseline up to 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 16
- Secondary Outcome Measures
Name Time Method Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 From Baseline up to Week 12 Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 From Baseline up to Week 12 Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 From Baseline up to Week 12
Trial Locations
- Locations (31)
Health Awareness, Inc., Jupiter
🇺🇸Jupiter, Florida, United States
Suncoast Research Associates - Miami
🇺🇸Miami, Florida, United States
Eximia Research - Raleigh
🇺🇸Raleigh, North Carolina, United States
FutureMeds Birmingham
🇬🇧Birmingham, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
St Pancras Clinical Research
🇬🇧London, United Kingdom
George Eliot Hospital NHS Trust - Diabetes and Endocrinology Centre
🇬🇧Nuneaton, United Kingdom
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Trovare Clinical Research
🇺🇸Bakersfield, California, United States
Eximia Research-CA, LLC
🇺🇸La Mesa, California, United States
Paradigm Clincial Research Centers, LLC., Wheat Ridge
🇺🇸Wheat Ridge, Colorado, 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
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Health Awareness - PSL
🇺🇸Port Saint Lucie, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
ARSN - NeuroStudies
🇺🇸Decatur, Georgia, United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
🇺🇸Meridian, Idaho, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Velocity Clinical Research - Cleveland
🇺🇸Beachwood, Ohio, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Clinical Trials of South Carolina - Berkeley
🇺🇸Moncks Corner, South Carolina, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
San Antonio Clinical Trials
🇺🇸San Antonio, Texas, United States
AMR Norfolk
🇺🇸Norfolk, Virginia, United States
LMC Clinical Research Inc. d.b.a. Centricity Research
🇨🇦Brampton, Canada
Okanagan Clinical Trials
🇨🇦Kelowna, Canada