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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
Who can join
Ages 18 to 80 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * No clinically significant conditions impacting quality or quantity of pain * Baseline Numeric Pain Scale ≥ 6 * Capable of answering text or email survey reminders * Low back pain with or without sciatica Exclusion Criteria: * Current use of other skeletal relaxants * Current use of other pain relievers * Current use of cimetidine or monoamine oxidase inhibitors
About the study
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
What is being tested
- Metaxalone 640 mg Oral Tablet (drug)
Sponsor: Primus Pharmaceuticals · Participants: 50 · Started: Nov 15, 2023
Contact the study team
- S Sodhi · Phone: 205-202-0739
Official record on ClinicalTrials.gov — NCT06157177
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.