Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Primus Pharmaceuticals
Study ID
NCT06157177
Phase
PHASE4
Status
Recruiting
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Conditions

  • Lumbar Spinal Stenosis
  • Sciatica Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 15, 2023
Status verified
Aug 2025
Primary completion
Nov 15, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active M640
    Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days
  • Placebo Comparator: Placebo
    Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Primary Outcome Measure

Change of Numeric Pain Scale [ Time Frame: Day 1 to Day 7 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
East Alabama Arthritis CenterAuburnAlabama36830-
Sean Wollaston, MDValley VillageCalifornia91607-
Arthritis and Osteoporosis CenterAventuraFlorida33180-
William Sunshine, MDBoca RatonFlorida33431-
Robert Levin, MDClearwaterFlorida33765
5. CZ RheumatologyCoral SpringsFlorida33065
4. Palm Beach Rheumatology and WellnessJupiterFlorida33458-
Family Arthritis CenterLoxahatchee GrovesFlorida33458-
Arthritis and Rheumatology Center of South FloridaMargateFlorida33063-
Arthritis and Osteoporosis Treatment and ResearchCenterMiamiFlorida33180
George Munoz, MD
[email protected]
CZ RheumatologyMiami BeachFlorida33140
Conrad Ziembinski, DO
[email protected]
Bay Area RheumatologyOldsmarFlorida34677
Rodney Daniel,, MD
[email protected]
Arthritis and Rheumatic Care CenterSouth MiamiFlorida33143-
Arthritis Research and Treatment CenterStockbridgeGeorgia30281-
Arthritis and Rheumatology Center of MISterling HeightsMichigan48310
Srijana Bakshi, MD
[email protected]
Jayashree Sinha, MD 1ClovisNew Mexico88101-
Carolina RheumatologyFayettevilleNorth Carolina28304-
Ohio Arthritis and Osteoporosis Center of Southwest OhioSpringboroOhio45066-
Cumberland RheumatologyCrossvilleTennessee38555
Sivalingam Kanagasegar, MD
[email protected]
Heritage Rheumatology & Arthritis CareColleyvilleTexas76034
Integrative Rheumatology of South TexasHarlingenTexas78550-
Southwest Research GroupMesquiteTexas75150-
DFW RheumatologyRed OakTexas75154-
Northern Virginia Center for ArthritisAnnandaleVirginia22003-

Find similar trials in Auburn, AL

By research site
East Alabama Arthritis Center· Auburn, ALSean Wollaston, MD· Valley Village, CAArthritis and Osteoporosis Center· Aventura, FLWilliam Sunshine, MD· Boca Raton, FLRobert Levin, MD· Clearwater, FL5. CZ Rheumatology· Coral Springs, FL

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