drugset / Trial / NCT06157177

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

NCT06157177

Phase 4 Recruiting 50 enrolled Primus Pharmaceuticals Illumination Health · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2023-11-15
Primary completion
2026-11-15
Completion
2026-11-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metaxalone Small molecule 640 mg Oral