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

March 6, 2024 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Lumbosacral Radiculopathy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Recruiting
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85018
        • Recruiting
        • Hope Research Institute
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Trovare Clinical Research
      • Banning, California, United States, 92220
        • Recruiting
        • Velocity Clinical Research - Banning
      • La Mesa, California, United States, 91942
        • Recruiting
        • Velocity Clinical Research - San Diego
      • Riverside, California, United States, 92501
        • Recruiting
        • Probe Clinical Research
      • Thousand Oaks, California, United States, 91320
        • Recruiting
        • Pain Management and Injury Relief
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Visionary Investigators Network
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Nature Coast Clinical Research - Crystal River
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • JY Research Institute
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Fleming Island Center for Clinical Research
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Convenient Medical Research
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33144
        • Recruiting
        • L&C Professional Medical Research Institute
      • Miami, Florida, United States, 33165
        • Recruiting
        • Medical Research of Westchester
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Brain & Spine Institute Of Port Orange
      • Seminole, Florida, United States, 33777
        • Recruiting
        • Accel Research Site - St. Petersburg/Largo
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • ClinCept Clinical Research
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Accel Research Sites - NeuroStudies
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Velocity Clinical Research - Savannah
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Velocity Clinical Research - Savannah Neurology Specialists
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Center for Pain Management and Rehab
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Velocity Clinical Research - Boise
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Recruiting
        • Healthcare Research Network II, LLC
      • Palos Hills, Illinois, United States, 60465
        • Recruiting
        • Essential Concepts Research Solutions
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • AMR Wichita East, KS
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • Velocity Clinical Research - Rockville
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital (BWH)
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research Coorporation
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • St. Louis Pain Consultants
      • Hazelwood, Missouri, United States, 63042
        • Recruiting
        • Healthcare Research Network
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Be Well Clinical Studies, LLC
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • AES Henderson
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • AMR Las Vegas (Clinical Research Consortium)
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
      • New York, New York, United States, 10017
        • Recruiting
        • AES New York
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research - Cincinnati
      • Dayton, Ohio, United States, 45432
        • Recruiting
        • META Medical Research Institute
      • Lima, Ohio, United States, 45805
        • Recruiting
        • NexGen Research
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • Clinical Investigations LLC.
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • AMR Norman
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Recruiting
        • Pacific Sports and Spine
      • Grants Pass, Oregon, United States, 97527
        • Recruiting
        • Velocity Clinical Research - Grants Pass
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research - Providence
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Clinical Trials of South Carolina - Charleston
    • Texas
      • Dallas, Texas, United States, 75234
        • Recruiting
        • AES Dallas Forth Worth
      • Houston, Texas, United States, 77079
        • Recruiting
        • Expert Pain
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Lubbock Spine Institute
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Be Well Clinical Studies - Austin
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • JBR Clinical Research
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Recruiting
        • Velocity Clinical Research - Hampton
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • AMR Norfolk
      • Portsmouth, Virginia, United States, 23703
        • Recruiting
        • Velocity Clinical Research - Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-548
Participants will receive VX-548 up to 12 weeks.
Drug: VX-548
Tablets for oral administration.
Placebo Comparator: Placebo
Participants will receive placebo matched to VX-548 up to 12 weeks.
Drug: Placebo
Tablets for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
Time Frame: Baseline, Week 12
Baseline, Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Week 14
From Day 1 up to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX23-548-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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