Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
- Registration Number
- NCT06176196
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
- Body weight greater than or equal to (>=)45 kilogram (kg)
- Body mass index (BMI) less than or equal to (<=) 40 kg/ meter square (m^2)
- Diagnosis of PLSR for greater than (>)3 months as per criteria pre-specified in the protocol
- Weekly average of daily NPRS score >=4 and <10 with limited variation in the 7-day Run-in Period
Key
- More than 3 missing daily NPRS scores during the 7-day Run-in Period
- Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol
- History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion)
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 receive VX-548 up to 12 weeks. Placebo Placebo Participants will receive placebo matched to VX-548 up to 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average of Daily leg 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 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Week 14
Trial Locations
- Locations (54)
Trovare Clinical Research
🇺🇸Bakersfield, California, United States
Velocity Clinical Research - Banning
🇺🇸Banning, California, United States
ARSN-Brain and Spine Institute
🇺🇸Port Orange, Florida, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Velocity Clinical Research - San Diego
🇺🇸La Mesa, California, United States
Probe Clinical Research
🇺🇸Riverside, California, United States
Pain Management and Injury Relief
🇺🇸Thousand Oaks, California, United States
Visionary Investigators Network
🇺🇸Aventura, Florida, United States
Nature Coast Clinical Research - Crystal River
🇺🇸Crystal River, Florida, United States
JY Research Institute
🇺🇸Cutler Bay, Florida, United States
Convenient Medical Research
🇺🇸Hialeah, Florida, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
Medical Research of Westchester
🇺🇸Miami, Florida, United States
Accel Research Site - St. Petersburg/Largo
🇺🇸Seminole, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
ClinCept Clinical Research
🇺🇸Columbus, Georgia, United States
Accel Research Sites - Neurostudies
🇺🇸Decatur, Georgia, United States
Velocity Clinical Research - Savannah Neurology Specialists
🇺🇸Savannah, Georgia, United States
Center for Pain Management and Rehab
🇺🇸Stockbridge, Georgia, United States
Velocity Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Velocity Clinical Research - Savannah
🇺🇸Savannah, Georgia, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Essential Concepts Research Solutions
🇺🇸Palos Hills, Illinois, United States
St. Louis Pain Consultants
🇺🇸Chesterfield, Missouri, United States
AMR Wichita East, KS
🇺🇸Wichita, Kansas, United States
Velocity Clinical Research - Rockville
🇺🇸Rockville, Maryland, United States
Brigham and Women's Hospital (BWH)
🇺🇸Boston, Massachusetts, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
MedVadis Research Coorporation
🇺🇸Waltham, Massachusetts, United States
Be Well Clinical Studies, LLC
🇺🇸Lincoln, Nebraska, United States
Synexus Clinical Research - Henderson
🇺🇸Henderson, Nevada, United States
AMR Las Vegas (Clinical Research Consortium)
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Albany Medical Center
🇺🇸Albany, New York, United States
META Medical Research Institute
🇺🇸Dayton, Ohio, United States
AES New York
🇺🇸New York, New York, United States
NexGen Research
🇺🇸Lima, Ohio, United States
Clinical Investigations LLC.
🇺🇸Edmond, Oklahoma, United States
AMR Norman
🇺🇸Norman, Oklahoma, United States
Pacific Sports and Spine
🇺🇸Eugene, Oregon, United States
Velocity Clinical Research - Grants Pass
🇺🇸Grants Pass, Oregon, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Lubbock Spine Institute
🇺🇸Lubbock, Texas, United States
Clinical Trials of South Carolina - Charleston
🇺🇸Charleston, South Carolina, United States
AES Dallas Forth Worth
🇺🇸Dallas, Texas, United States
Expert Pain
🇺🇸Houston, Texas, United States
Be Well Clinical Studies - Austin
🇺🇸Round Rock, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Velocity Clinical Research - Portsmouth
🇺🇸Portsmouth, Virginia, United States
Velocity Clinical Research - Hampton
🇺🇸Hampton, Virginia, United States
AMR Norfolk
🇺🇸Norfolk, Virginia, United States