Effacacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Study Overview
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Brief Summary
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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

Detailed Description
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Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.

Official Title
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Effacacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica

Conditions
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Sciatica Acute, Lumbar Spinal Stenosis

Intervention / Treatment
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* Drug: Metaxalone 640 mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinically significant conditions impacting quality or quanity 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 releivers Current use of cimetadine or monoamine oxidase inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active M640<br>Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days | Drug: Metaxalone 640 mg Oral Tablet<br>* Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.<br>* Other names: metaxalone micronized;|
| Placebo Comparator: Placebo<br>Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days | Drug: Metaxalone 640 mg Oral Tablet<br>* Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.<br>* Other names: metaxalone micronized;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Numeric Pain Scale | Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7 | Day 1 to Day 7 |