Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
NCT ID: NCT06176196
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2023-12-13
2024-10-16
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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VX-548
Participants will receive VX-548 up to 12 weeks.
VX-548
Tablets for oral administration.
Placebo
Participants will receive placebo matched to VX-548 up to 12 weeks.
Placebo
Tablets for oral administration.
Interventions
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VX-548
Tablets for oral administration.
Placebo
Tablets for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Hope Research Institute
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Trovare Clinical Research
Bakersfield, California, United States
Velocity Clinical Research - Banning
Banning, California, 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
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Convenient Medical Research
Hialeah, 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
ARSN-Brain and Spine Institute
Port Orange, 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
Velocity Clinical Research - Savannah
Savannah, Georgia, United States
Center for Pain Management and Rehab
Stockbridge, Georgia, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Essential Concepts Research Solutions
Palos Hills, Illinois, 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
MedVadis Research Coorporation
Waltham, Massachusetts, United States
St. Louis Pain Consultants
Chesterfield, Missouri, United States
Healthcare Research Network
Hazelwood, Missouri, 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
Albany Medical Center
Albany, New York, United States
AES New York
New York, New York, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, United States
META Medical Research Institute
Dayton, Ohio, 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
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
Lubbock Spine Institute
Lubbock, 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 - Hampton
Hampton, Virginia, United States
AMR Norfolk
Norfolk, Virginia, United States
Velocity Clinical Research - Portsmouth
Portsmouth, Virginia, United States
Countries
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Other Identifiers
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VX23-548-109
Identifier Type: -
Identifier Source: org_study_id
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