Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Description

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

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Study Overview

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Study Details

Study overview

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

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

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Condition
Sciatica Acute
Intervention / Treatment

-

Contacts and Locations

Auburn

East Alabama Arthritis Center, Auburn, Alabama, United States, 36830

Valley Village

Sean Wollaston, MD, Valley Village, California, United States, 91607

Aventura

Arthritis and Osteoporosis Center, Aventura, Florida, United States, 33180

Boca Raton

William Sunshine, MD, Boca Raton, Florida, United States, 33431

Clearwater

Robert Levin, MD, Clearwater, Florida, United States, 33765

Coral Springs

5. CZ Rheumatology, Coral Springs, Florida, United States, 33065

Jupiter

4. Palm Beach Rheumatology and Wellness, Jupiter, Florida, United States, 33458

Loxahatchee Groves

Family Arthritis Center, Loxahatchee Groves, Florida, United States, 33458

Margate

Arthritis and Rheumatology Center of South Florida, Margate, Florida, United States, 33063

South Miami

Arthritis and Rheumatic Care Center, South Miami, Florida, United States, 33143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Current use of other skeletal relaxants
  • * Current use of other pain relievers
  • * Current use of cimetidine or monoamine oxidase inhibitors

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Primus Pharmaceuticals,

S Sodhi, STUDY_DIRECTOR, Illumination Health

Study Record Dates

2025-11-15