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NCT Number: NCT06157177

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

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

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Key information

Conditions

Sciatica Acute Bone Diseases Lumbar Spinal Stenosis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East Alabama Arthritis Center, Auburn, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metaxalone 640 mg Oral Tablet

Drug

Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

Other names: Skelaxin un-micronized, M640, metaxalone micronized

Primary outcomes

  1. Change of Numeric Pain Scale

    Time frame: Day 1 to Day 7

    Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

S Sodhi

CONTACT

[email protected]

205-202-0739

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • Illumination Health

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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