Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Launched by PRIMUS PHARMACEUTICALS · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new version of a medication called metaxalone to see if it can help reduce pain in the lower back and legs, specifically for conditions like sciatica and lumbar spinal stenosis. The researchers want to find out if this modified medication is more effective than a placebo (a look-alike pill with no active ingredients). Participants in the trial will be between 18 and 80 years old and must have recently experienced significant back or leg pain. They will be asked to rate their pain and how it affects their daily activities and sleep on the first day and again seven days after starting treatment.

To be eligible for this trial, participants should not have any serious health issues that could affect their pain and must have a pain level of at least 6 on a scale from 0 to 10. They should be able to respond to surveys through text or email. However, people currently taking other muscle relaxants, pain medications, or specific types of drugs that could interfere with the study will not be able to participate. This trial is currently recruiting participants, and everyone's input will help researchers understand the effectiveness of the new medication.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Current use of other skeletal relaxants
• • Current use of other pain relievers
• • Current use of cimetidine or monoamine oxidase inhibitors