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Testing a new medication for low back and leg pain relief.

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

Phase 4 Interventional Primus Pharmaceuticals · NCT06157177

This study is testing a new medication to see if it can help people aged 18 to 80 with back and leg pain feel better.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorPrimus Pharmaceuticals Industry-sponsored
Locations24 sites (Auburn, Alabama and 23 other locations)
Trial IDNCT06157177 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a modified metaxalone 640 mg in alleviating pain associated with acute lumbosacral musculoskeletal conditions, specifically sciatica and lumbar spinal stenosis. Participants aged 18 to 80 with newly occurring back or leg pain will be randomly assigned to receive either the active treatment or a placebo in a double-blind manner. The study will assess pain levels, physical activity interference, and sleep disruption through surveys conducted before treatment and one week after. The trial is designed to gather robust data on the medication's efficacy compared to a look-alike substance without active ingredients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 experiencing newly occurring low back pain with or without sciatica and a baseline pain score of 6 or higher.

Not a fit: Patients currently using other skeletal relaxants, pain relievers, or specific medications like cimetidine or monoamine oxidase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve quality of life for patients suffering from acute low back and leg pain.

How similar studies have performed: Other studies have shown promise in using modified formulations of existing medications for pain relief, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Auburn, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sciatica AcuteLumbar Spinal Stenosis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.