Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
NCT ID: NCT06157177
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2023-11-15
2025-11-15
Brief Summary
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* Amount and quality of pain
* Interference with physical activity
* Interference with sleep
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active M640
Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days
Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Placebo
Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days
Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Interventions
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Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 pain relievers
* Current use of cimetidine or monoamine oxidase inhibitors
18 Years
80 Years
ALL
Yes
Sponsors
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Illumination Health
NETWORK
Primus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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S Sodhi
Role: STUDY_DIRECTOR
Illumination Health
Locations
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East Alabama Arthritis Center
Auburn, Alabama, United States
Sean Wollaston, MD
Valley Village, California, United States
Arthritis and Osteoporosis Center
Aventura, Florida, United States
William Sunshine, MD
Boca Raton, Florida, United States
Robert Levin, MD
Clearwater, Florida, United States
5. CZ Rheumatology
Coral Springs, Florida, United States
4. Palm Beach Rheumatology and Wellness
Jupiter, Florida, United States
Family Arthritis Center
Loxahatchee Groves, Florida, United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, United States
Arthritis and Rheumatic Care Center
South Miami, Florida, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States
Jayashree Sinha, MD 1
Clovis, New Mexico, United States
Carolina Rheumatology
Fayetteville, North Carolina, United States
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
Springboro, Ohio, United States
Heritage Rheumatology & Arthritis Care
Colleyville, Texas, United States
Integrative Rheumatology of South Texas
Harlingen, Texas, United States
Southwest Research Group
Mesquite, Texas, United States
DFW Rheumatology
Red Oak, Texas, United States
Northern Virginia Center for Arthritis
Annandale, Virginia, United States
Countries
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Other Identifiers
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PMMSS-01
Identifier Type: -
Identifier Source: org_study_id
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