Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

Last updated: October 29, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

2

Condition

Pain

Radiculopathy

Treatment

Placebo

VX-548

Clinical Study ID

NCT06176196
VX23-548-109
  • Ages 18-70
  • All Genders

Study Summary

The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • 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 theprotocol

  • Weekly average of daily NPRS score >=4 and <10 with limited variation in the 7-dayRun-in Period

Exclusion

Key Exclusion Criteria:

  • 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 theprotocol

  • History of prior lumbar spine surgery (e.g., discectomies, laminectomies,foraminotomies, or fusion)

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 218
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 13, 2023
Estimated Completion Date:
October 16, 2024

Connect with a study center

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Trovare Clinical Research

    Bakersfield, California 93301
    United States

    Site Not Available

  • Velocity Clinical Research - Banning

    Banning, California 92220
    United States

    Site Not Available

  • Velocity Clinical Research - San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Probe Clinical Research

    Riverside, California 92501
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Visionary Investigators Network

    Aventura, Florida 33180
    United States

    Site Not Available

  • Nature Coast Clinical Research - Crystal River

    Crystal River, Florida 34429
    United States

    Site Not Available

  • JY Research Institute

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Convenient Medical Research

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • L&C Professional Medical Research Institute

    Miami, Florida 33144
    United States

    Site Not Available

  • Medical Research of Westchester

    Miami, Florida 33165
    United States

    Site Not Available

  • ARSN-Brain and Spine Institute

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Brain & Spine Institute Of Port Orange

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Accel Research Site - St. Petersburg/Largo

    Seminole, Florida 33777
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • ClinCept Clinical Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Accel Research Sites - Neurostudies

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Velocity Clinical Research - Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research - Savannah Neurology Specialists

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Center for Pain Management and Rehab

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Velocity Clinical Research - Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Essential Concepts Research Solutions

    Palos Hills, Illinois 60465
    United States

    Site Not Available

  • AMR Wichita East, KS

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Velocity Clinical Research - Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • MedVadis Research Coorporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • St. Louis Pain Consultants

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • AES Henderson

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Synexus Clinical Research - Henderson

    Henderson, Nevada 89052
    United States

    Site Not Available

  • AMR Las Vegas (Clinical Research Consortium)

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • AES New York

    New York, New York 10017
    United States

    Site Not Available

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

    Site Not Available

  • NexGen Research

    Lima, Ohio 45805
    United States

    Site Not Available

  • Clinical Investigations LLC.

    Edmond, Oklahoma 73034
    United States

    Site Not Available

  • AMR Norman

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Pacific Sports and Spine

    Eugene, Oregon 97404
    United States

    Site Not Available

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • AES Dallas Forth Worth

    Dallas, Texas 75234
    United States

    Site Not Available

  • Expert Pain

    Houston, Texas 77079
    United States

    Site Not Available

  • Lubbock Spine Institute

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Be Well Clinical Studies - Austin

    Round Rock, Texas 78681
    United States

    Site Not Available

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Velocity Clinical Research - Hampton

    Hampton, Virginia 23666
    United States

    Site Not Available

  • AMR Norfolk

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Velocity Clinical Research - Portsmouth

    Portsmouth, Virginia 23703
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.