Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

NCT06157177 · tracked via the Priya Life Science USA tracker

Sponsor

Primus Pharmaceuticals

Phase

Phase 4

Started

2023-11-15

Last updated

2026-09-14

Condition(s) studied

Sciatica AcuteLumbar Spinal Stenosis

Investigational drug(s) / intervention(s)

Metaxalone 640 mg Oral Tablet

Metaxalone 640 mg Oral Tablet: Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Change of Numeric Pain Scale — Day 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

Trial sites (24)

Facility	City	Region	Status
East Alabama Arthritis Center	Auburn	Alabama	Active Not Recruiting
Sean Wollaston, MD	Valley Village	California	Active Not Recruiting
Arthritis and Osteoporosis Center	Aventura	Florida	Active Not Recruiting
William Sunshine, MD	Boca Raton	Florida	Active Not Recruiting
Robert Levin, MD	Clearwater	Florida	Recruiting
5. CZ Rheumatology	Coral Springs	Florida	Recruiting
4. Palm Beach Rheumatology and Wellness	Jupiter	Florida	Active Not Recruiting
Family Arthritis Center	Loxahatchee Groves	Florida	Active Not Recruiting
Arthritis and Rheumatology Center of South Florida	Margate	Florida	Active Not Recruiting
Arthritis and Osteoporosis Treatment and ResearchCenter	Miami	Florida	Recruiting
CZ Rheumatology	Miami Beach	Florida	Recruiting
Bay Area Rheumatology	Oldsmar	Florida	Recruiting
Arthritis and Rheumatic Care Center	South Miami	Florida	Active Not Recruiting
Arthritis Research and Treatment Center	Stockbridge	Georgia	Active Not Recruiting
Arthritis and Rheumatology Center of MI	Sterling Heights	Michigan	Recruiting
Jayashree Sinha, MD 1	Clovis	New Mexico	Active Not Recruiting
Carolina Rheumatology	Fayetteville	North Carolina	Active Not Recruiting
Ohio Arthritis and Osteoporosis Center of Southwest Ohio	Springboro	Ohio	Active Not Recruiting
Cumberland Rheumatology	Crossville	Tennessee	Recruiting
Heritage Rheumatology & Arthritis Care	Colleyville	Texas	Recruiting
Integrative Rheumatology of South Texas	Harlingen	Texas	Active Not Recruiting
Southwest Research Group	Mesquite	Texas	Active Not Recruiting
DFW Rheumatology	Red Oak	Texas	Active Not Recruiting
Northern Virginia Center for Arthritis	Annandale	Virginia	Active Not Recruiting

More Primus Pharmaceuticals trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06157177 on ClinicalTrials.gov ↗ ← All trials in the USA