Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Last updated: August 5, 2025
Sponsor: Primus Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Spinal Stenosis

Sciatica

Spondylolisthesis

Treatment

Metaxalone 640 mg Oral Tablet

Clinical Study ID

NCT06157177
PMMSS-01
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Current use of other skeletal relaxants

  • Current use of other pain relievers

  • Current use of cimetidine or monoamine oxidase inhibitors

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Metaxalone 640 mg Oral Tablet
Phase: 4
Study Start date:
November 15, 2023
Estimated Completion Date:
November 15, 2025

Study Description

Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.

Connect with a study center

  • East Alabama Arthritis Center

    Auburn, Alabama 36830
    United States

    Site Not Available

  • Illumination Health

    Hoover, Alabama 35224
    United States

    Site Not Available

  • Sean Wollaston, MD

    Valley Village, California 91607
    United States

    Site Not Available

  • Arthritis and Osteoporosis Center

    Aventura, Florida 33180
    United States

    Site Not Available

  • William Sunshine, MD

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Robert Levin, MD

    Clearwater, Florida 33765
    United States

    Site Not Available

  • 5. CZ Rheumatology

    Coral Springs, Florida 33065
    United States

    Site Not Available

  • 4. Palm Beach Rheumatology and Wellness

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Family Arthritis Center

    Loxahatchee Groves, Florida 33458
    United States

    Site Not Available

  • Arthritis and Rheumatology Center of South Florida

    Margate, Florida 33063
    United States

    Site Not Available

  • Arthritis and Rheumatic Care Center

    South Miami, Florida 33143
    United States

    Site Not Available

  • Arthritis Research and Treatment Center

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Jayashree Sinha, MD 1

    Clovis, New Mexico 88101
    United States

    Site Not Available

  • Carolina Rheumatology

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Ohio Arthritis and Osteoporosis Center of Southwest Ohio

    Springboro, Ohio 45066
    United States

    Site Not Available

  • Southern Ohio Rheumatology

    Wheelersburg, Ohio 45694
    United States

    Site Not Available

  • Heritage Rheumatology & Arthritis Care

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Integrative Rheumatology of South Texas

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Southwest Research Group

    Mesquite, Texas 75150
    United States

    Site Not Available

  • DFW Rheumatology

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Northern Virginia Center for Arthritis

    Annandale, Virginia 22003
    United States

    Site Not Available

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