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Painful Lumbosacral RadiculopathyPhase 2NCT06176196

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

A Phase 2 study testing VX-548 in people with Painful Lumbosacral Radiculopathy, run by Vertex Pharmaceuticals Incorporated at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Painful Lumbosacral Radiculopathy
What is being tested?
VX-548
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
54 sitesUnited States
Study dates
13 Dec 2023to 16 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Trovare Clinical Research

    Bakersfield, California, 93301

  • Velocity Clinical Research - Banning

    Banning, California, 92220

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts, 02115

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina, 29406

  • St. Louis Pain Consultants

    Chesterfield, Missouri, 63017

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

  • ClinCept Clinical Research

    Columbus, Georgia, 31904

  • Nature Coast Clinical Research - Crystal River

    Crystal River, Florida, 34429

  • JY Research Institute

    Cutler Bay, Florida, 33189

  • AES Dallas Forth Worth

    Dallas, Texas, 75234

  • META Medical Research Institute

    Dayton, Ohio, 45432

  • Accel Research Sites - Neurostudies

    Decatur, Georgia, 30030

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • Clinical Investigations LLC.

    Edmond, Oklahoma, 73034

  • Pacific Sports and Spine

    Eugene, Oregon, 97404

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97527

  • Velocity Clinical Research - Hampton

    Hampton, Virginia, 23666

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Synexus Clinical Research - Henderson

    Henderson, Nevada, 89052

  • Convenient Medical Research

    Hialeah, Florida, 33013

  • Expert Pain

    Houston, Texas, 77079

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942

  • AMR Las Vegas (Clinical Research Consortium)

    Las Vegas, Nevada, 89119

  • NexGen Research

    Lima, Ohio, 45805

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516

  • Lubbock Spine Institute

    Lubbock, Texas, 79410

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • L&C Professional Medical Research Institute

    Miami, Florida, 33144

  • Medical Research of Westchester

    Miami, Florida, 33165

  • AES New York

    New York, New York, 10017

  • AMR Norfolk

    Norfolk, Virginia, 23502

  • AMR Norman

    Norman, Oklahoma, 73069

  • Essential Concepts Research Solutions

    Palos Hills, Illinois, 60465

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • ARSN-Brain and Spine Institute

    Port Orange, Florida, 32127

  • Velocity Clinical Research - Portsmouth

    Portsmouth, Virginia, 23703

  • Probe Clinical Research

    Riverside, California, 92501

  • Velocity Clinical Research - Rockville

    Rockville, Maryland, 20854

  • Be Well Clinical Studies - Austin

    Round Rock, Texas, 78681

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

  • Velocity Clinical Research - Savannah Neurology Specialists

    Savannah, Georgia, 31406

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406

  • Accel Research Site - St. Petersburg/Largo

    Seminole, Florida, 33777

  • Center for Pain Management and Rehab

    Stockbridge, Georgia, 30281

  • Pain Management and Injury Relief

    Thousand Oaks, California, 91320

  • MedVadis Research Coorporation

    Waltham, Massachusetts, 02451

  • AMR Wichita East, KS

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: 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.

Being tested
VX-548, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VX-548Drug

    Also called Suzetrigine

    Tablets for oral administration.

  • PlaceboDrug

    Tablets for oral administration.

Study groups in NCT06176196
Study groupRoleWhat they receive
VX-548ExperimentalParticipants will receive VX-548 up to 12 weeks.
Receives: Drug: VX-548
PlaceboPlacebo comparatorParticipants will receive placebo matched to VX-548 up to 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)

    Measured: Baseline, Week 12

Secondary outcomes (2)

  1. Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)

    Measured: Baseline, Week 12

  2. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start13 Dec 2023
  3. Primary completion2 Oct 2024
  4. Study completion16 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176196
Sponsor's protocol ID
VX23-548-109
Status last verified
Sep 2025
First submitted
10 Dec 2023
Last updated
1 Oct 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Siddiqui A, Xu JL, Abramowicz AE. Suzetrigine for the Treatment of Acute Pain: Comment. Anesthesiology. 2026 Feb 1;144(2):495-496. doi: 10.1097/ALN.0000000000005822. Epub 2025 Dec 11. No abstract available.

    PubMed 41384808

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VX-548 in people with Painful Lumbosacral Radiculopathy, run by Vertex Pharmaceuticals Incorporated at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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