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Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Testing M640 for lower back pain relief in clinical trial.

Recruiting
18-80 years
All
Phase 4

This study is testing a new version of a drug called metaxalone to see if it helps with low back and leg pain. Metaxalone is a type of medicine that helps relax muscles. The study includes people aged 18 to 80 who have recently started having back or leg pain. Participants will be split into two groups: one taking the actual medicine and the other taking a placebo (a substance that looks like the medicine but has no active ingredients). This is a double-blind study, meaning neither the participants nor the researchers know who is getting the real drug or the placebo, to ensure fair results.

Participants will answer surveys on the first day and again after seven days about their pain levels, how pain affects their activities, and their sleep quality.

  • Study Duration: One week with surveys on Day 1 and Day 7.
  • Eligibility: Must have a pain score of 6 or higher and no other muscle relaxant use.
  • Risks: Cannot use other pain relievers or certain medicines like cimetidine.

Consider if you fit the eligibility criteria and are comfortable with the study conditions before deciding to participate.

Study details
    Sciatica Acute
    Lumbar Spinal Stenosis

NCT06157177

Primus Pharmaceuticals

10 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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