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RecruitingAccepts healthy volunteersPhase 4

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Primus Pharmaceuticals · with Illumination Health · NCT06157177

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
50
US sites recruiting
8
Study start
November 15, 2023
Record last updated
September 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Metaxalone 640 mg Oral Tablet

Conditions: Sciatica Acute; Lumbar Spinal Stenosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Robert Levin, MD

    Clearwater, FL 33765

    Site contact: simi@illumination.health

  • 5. CZ Rheumatology

    Coral Springs, FL 33065

    Site contact: simi@illumination.health

  • Arthritis and Osteoporosis Treatment and ResearchCenter

    Miami, FL 33180

    Site contact: George Munoz, MD · simi@illumination.health

  • CZ Rheumatology

    Miami Beach, FL 33140

    Site contact: Conrad Ziembinski, DO · simi@illumination.health

  • Bay Area Rheumatology

    Oldsmar, FL 34677

    Site contact: Rodney Daniel,, MD · simi@illumination.health

  • Arthritis and Rheumatology Center of MI

    Sterling Heights, MI 48310

    Site contact: Srijana Bakshi, MD · simi@illumination.health

  • Cumberland Rheumatology

    Crossville, TN 38555

    Site contact: Sivalingam Kanagasegar, MD · simi@illumination.health

  • Heritage Rheumatology & Arthritis Care

    Colleyville, TX 76034

    Site contact: simi@illumination.health

Study contacts (from the official record)

  • S Sodhi · 205-202-0739 · simi@illumination.health
All healthy volunteers studies in Florida →
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions. (NCT06157177) | Bored Studies