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Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Nov 15, 2025 to Nov 15, 2026
    • Study sites: 19 to 24
    v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 19 of 19 sites
    v6
  4. Study sites: 20 to 19v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 21 to 20v3
  2. Study sites: 1 to 21
    • Eligibility criteria revised
    • Study title revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06157177
Lead Sponsor Primus Pharmaceuticals
Collaborators: Illumination Health
Conditions
(from sponsor)		 Sciatica Acute, Lumbar Spinal Stenosis
Related terms Spinal Stenosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov