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Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

RecruitingPhase 4Ages 18 Years - 80 YearsAllPrimus Pharmaceuticals
NCT06157177 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Metaxalone 640 mg Oral Tablet
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Where

24 sites
East Alabama Arthritis Center
Auburn, United States
Sean Wollaston, MD
Valley Village, United States
Arthritis and Osteoporosis Center
Aventura, United States
William Sunshine, MD
Boca Raton, United States
Robert Levin, MD
Clearwater, United States
5. CZ Rheumatology
Coral Springs, United States
4. Palm Beach Rheumatology and Wellness
Jupiter, United States
Family Arthritis Center
Loxahatchee Groves, United States

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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