M640 for Acute Low Back and Leg Pain
This study is looking at whether a modified version of metaxalone 640 mg, a medication for muscle discomfort, can help reduce acute (newly occurring) low back and leg pain. You might be able to join if you are between 18 and 80 years old, have new back or leg pain, and your pain level is 6 or higher on a Numeric Pain Scale. The study will compare metaxalone 640 mg to a look-alike substance without active medicine. Success will be measured by changes in your pain from Day 1 to Day 7. The current recruitment status is unclear.
- Study design
- This is a double-blind, randomized, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving the active drug or a placebo (inactive substance). About 50 participants are planned for this initial study.
- What's involved
- You will answer questions about your pain, physical activity, and sleep on Day 1 before treatment, and again 7 days after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain will be measured from Day 1 to Day 7 after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
At a glance
Conditions
Where it's being run
24 sites across 11 statesStudy leadership
- S Sodhi · STUDY_DIRECTOR · Illumination Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change of Numeric Pain ScaleDay 1 to Day 7
Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7