Actively Recruiting
Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Led by Primus Pharmaceuticals · Updated on 2026-05-12
50
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Primus Pharmaceuticals
Lead Sponsor
I
Illumination Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.
CONDITIONS
Brief Title
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No clinically significant conditions impacting quality or quantity of pain
- Baseline Numeric Pain Scale 65 6
- Capable of answering text or email survey reminders
- Low back pain with or without sciatica
- Age between 18 and 80 years
You will not qualify if you...
- Current use of other skeletal relaxants
- Current use of other pain relievers
- Current use of cimetidine or monoamine oxidase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take metaxalone 640 mg or placebo orally every 6 hours for 7 days alongside standard care for acute lumbosacral musculoskeletal conditions.
Daily medication intake for 7 days
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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