Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
NCT06157177
This study is recruiting at 8 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
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
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Sciatica Acute
- Lumbar Spinal Stenosis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 4
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Primus Pharmaceuticals
- Last updated on ClinicalTrials.gov
- September 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 5
- Robert Levin, MD · Clearwater, FL
- 5. CZ Rheumatology · Coral Springs, FL
- Arthritis and Osteoporosis Treatment and ResearchCenter · Miami, FL
- CZ Rheumatology · Miami Beach, FL
- Bay Area Rheumatology · Oldsmar, FL
Michigan · 1
- Arthritis and Rheumatology Center of MI · Sterling Heights, MI
Tennessee · 1
- Cumberland Rheumatology · Crossville, TN
Texas · 1
- Heritage Rheumatology & Arthritis Care · Colleyville, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.