NCT06157177

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about: * Amount and quality of pain * Interference with physical activity * Interference with sleep

Detailed description

Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.

Conditions

• Sciatica Acute
• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DRUG	Metaxalone 640 mg Oral Tablet	Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2023-12-05
• Last updated: 2025-08-07

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study