Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06157177
Study type	Interventional
Source	Primus Pharmaceuticals
Contact	S Sodhi
Phone	205-202-0739
Email	simi@illumination.health
Status	Recruiting
Phase	Phase 4
Start date	November 15, 2023
Completion date	November 15, 2025

View Details

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