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RECRUITING Phase 4 ClinicalTrials.gov

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Sponsor: Primus Pharmaceuticals • ClinicalTrials.gov ID: NCT06157177

Registry updated: 2026-09-14
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Description

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

Interventions

  • Metaxalone 640 mg Oral Tablet (Drug)
    Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

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

Conditions

Sciatica Acute Lumbar Spinal Stenosis

Locations

  • East Alabama Arthritis Center — Auburn, Alabama, United States
  • Sean Wollaston, MD — Valley Village, California, United States
  • Arthritis and Osteoporosis Center — Aventura, Florida, United States
  • William Sunshine, MD — Boca Raton, Florida, United States
  • Robert Levin, MD — Clearwater, Florida, United States
  • 5. CZ Rheumatology — Coral Springs, Florida, United States
  • 4. Palm Beach Rheumatology and Wellness — Jupiter, Florida, United States
  • Family Arthritis Center — Loxahatchee Groves, Florida, United States
  • Arthritis and Rheumatology Center of South Florida — Margate, Florida, United States
  • Arthritis and Osteoporosis Treatment and ResearchCenter — Miami, Florida, United States
  • CZ Rheumatology — Miami Beach, Florida, United States
  • Bay Area Rheumatology — Oldsmar, Florida, United States
  • Arthritis and Rheumatic Care Center — South Miami, Florida, United States
  • Arthritis Research and Treatment Center — Stockbridge, Georgia, United States
  • Arthritis and Rheumatology Center of MI — Sterling Heights, Michigan, United States
  • Jayashree Sinha, MD 1 — Clovis, New Mexico, United States
  • Carolina Rheumatology — Fayetteville, North Carolina, United States
  • Ohio Arthritis and Osteoporosis Center of Southwest Ohio — Springboro, Ohio, United States
  • Cumberland Rheumatology — Crossville, Tennessee, United States
  • Heritage Rheumatology & Arthritis Care — Colleyville, Texas, United States
  • Integrative Rheumatology of South Texas — Harlingen, Texas, United States
  • Southwest Research Group — Mesquite, Texas, United States
  • DFW Rheumatology — Red Oak, Texas, United States
  • Northern Virginia Center for Arthritis — Annandale, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record