Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Sciatica Acute, Lumbar Spinal Stenosis

In brief

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

Key facts

Study ID

NCT06157177

Run by

Primus Pharmaceuticals

People needed

50

Starts

2023-11-15

Expected to finish

2026-11-15

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• CZ Rheumatology — Miami Beach, Florida, United States (enrolling)
• Bay Area Rheumatology — Oldsmar, Florida, United States (enrolling)
• Cumberland Rheumatology — Crossville, Tennessee, United States (enrolling)
• Heritage Rheumatology & Arthritis Care — Colleyville, Texas, United States (enrolling)
• 5. CZ Rheumatology — Coral Springs, Florida, United States (enrolling)
• Robert Levin, MD — Clearwater, Florida, United States (enrolling)
• Arthritis and Rheumatology Center of MI — Sterling Heights, Michigan, United States (enrolling)
• Arthritis and Osteoporosis Treatment and ResearchCenter — Miami, Florida, United States (enrolling)
• 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
• Integrative Rheumatology of South Texas — Harlingen, Texas, United States
• Southwest Research Group — Mesquite, Texas, United States
• DFW Rheumatology — Red Oak, Texas, United States
• East Alabama Arthritis Center — Auburn, Alabama, United States
• Northern Virginia Center for Arthritis — Annandale, Virginia, 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
• 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

Full record on ClinicalTrials.gov

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