Actively Recruiting
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Led by Primus Pharmaceuticals · Updated on 2026-05-12
50
Participants Needed
24
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Primus Pharmaceuticals
Lead Sponsor
I
Illumination Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Low back pain with or without sciatica
- Numeric Pain Scale score of 6 or higher at baseline
- No significant other health conditions affecting pain quality or quantity
- Able to answer text or email survey reminders
You will not qualify if you...
- Currently using other skeletal muscle relaxants
- Currently using other pain relievers
- Currently taking cimetidine or monoamine oxidase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
East Alabama Arthritis Center
Auburn, Alabama, United States, 36830
Active, Not Recruiting
2
Sean Wollaston, MD
Valley Village, California, United States, 91607
Active, Not Recruiting
3
Arthritis and Osteoporosis Center
Aventura, Florida, United States, 33180
Active, Not Recruiting
4
William Sunshine, MD
Boca Raton, Florida, United States, 33431
Active, Not Recruiting
5
Robert Levin, MD
Clearwater, Florida, United States, 33765
Actively Recruiting
6
5. CZ Rheumatology
Coral Springs, Florida, United States, 33065
Actively Recruiting
7
4. Palm Beach Rheumatology and Wellness
Jupiter, Florida, United States, 33458
Active, Not Recruiting
8
Family Arthritis Center
Loxahatchee Groves, Florida, United States, 33458
Active, Not Recruiting
9
Arthritis and Rheumatology Center of South Florida
Margate, Florida, United States, 33063
Active, Not Recruiting
10
Arthritis and Osteoporosis Treatment and ResearchCenter
Miami, Florida, United States, 33180
Actively Recruiting
11
CZ Rheumatology
Miami Beach, Florida, United States, 33140
Actively Recruiting
12
Bay Area Rheumatology
Oldsmar, Florida, United States, 34677
Actively Recruiting
13
Arthritis and Rheumatic Care Center
South Miami, Florida, United States, 33143
Active, Not Recruiting
14
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States, 30281
Active, Not Recruiting
15
Arthritis and Rheumatology Center of MI
Sterling Heights, Michigan, United States, 48310
Actively Recruiting
16
Jayashree Sinha, MD 1
Clovis, New Mexico, United States, 88101
Active, Not Recruiting
17
Carolina Rheumatology
Fayetteville, North Carolina, United States, 28304
Active, Not Recruiting
18
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
Springboro, Ohio, United States, 45066
Active, Not Recruiting
19
Cumberland Rheumatology
Crossville, Tennessee, United States, 38555
Actively Recruiting
20
Heritage Rheumatology & Arthritis Care
Colleyville, Texas, United States, 76034
Actively Recruiting
21
Integrative Rheumatology of South Texas
Harlingen, Texas, United States, 78550
Active, Not Recruiting
22
Southwest Research Group
Mesquite, Texas, United States, 75150
Active, Not Recruiting
23
DFW Rheumatology
Red Oak, Texas, United States, 75154
Active, Not Recruiting
24
Northern Virginia Center for Arthritis
Annandale, Virginia, United States, 22003
Active, Not Recruiting
Research Team
S
S Sodhi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here