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Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

NCT06157177 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-12

No results posted yet for this 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

Conditions

  • Sciatica Acute
  • Lumbar Spinal Stenosis

Interventions

DRUG

Metaxalone 640 mg Oral Tablet

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

Sponsors & Collaborators

  • Illumination Health

    collaborator NETWORK

  • Primus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • S Sodhi · Illumination Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2026-11-15
Completion
2026-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157177 on ClinicalTrials.gov