NCT06176196

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Painful Lumbosacral Radiculopathy

Interventions

Type	Name	Description
DRUG	VX-548	Tablets for oral administration.
DRUG	Placebo	Tablets for oral administration.

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-10-02
• Completion: 2024-10-16
• First posted: 2023-12-19
• Last updated: 2025-10-01

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated drug study