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OpenTrials
Completed

NCT Number: NCT06176196

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

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

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Key information

Conditions

Painful Lumbosacral Radiculopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Research Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-548

Drug

Tablets for oral administration.

Other names: Suzetrigine

Placebo

Drug

Tablets for oral administration.

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

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

    Time frame: Baseline, Week 12

  2. 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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.