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Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Sponsor: Primus Pharmaceuticals
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
Official title: Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-11-15
Completion Date
2025-11-15
Last Updated
2025-08-07
Healthy Volunteers
Yes
Conditions
Interventions
Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Locations (19)
East Alabama Arthritis Center
Auburn, Alabama, United States
Sean Wollaston, MD
Valley Village, California, United States
Arthritis and Osteoporosis Center
Aventura, Florida, United States
William Sunshine, MD
Boca Raton, Florida, United States
Robert Levin, MD
Clearwater, Florida, United States
5. CZ Rheumatology
Coral Springs, Florida, United States
4. Palm Beach Rheumatology and Wellness
Jupiter, Florida, United States
Family Arthritis Center
Loxahatchee Groves, Florida, United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, United States
Arthritis and Rheumatic Care Center
South Miami, Florida, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States
Jayashree Sinha, MD 1
Clovis, New Mexico, United States
Carolina Rheumatology
Fayetteville, North Carolina, United States
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
Springboro, Ohio, United States
Heritage Rheumatology & Arthritis Care
Colleyville, Texas, United States
Integrative Rheumatology of South Texas
Harlingen, Texas, United States
Southwest Research Group
Mesquite, Texas, United States
DFW Rheumatology
Red Oak, Texas, United States
Northern Virginia Center for Arthritis
Annandale, Virginia, United States