Lumbar Spinal Stenosis Clinical Trial
Official title:
Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 15, 2025 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northern Virginia Center for Arthritis | Annandale | Virginia |
United States | East Alabama Arthritis Center | Auburn | Alabama |
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 | Jayashree Sinha, MD 1 | Clovis | New Mexico |
United States | Heritage Rheumatology & Arthritis Care | Colleyville | Texas |
United States | 5. CZ Rheumatology | Coral Springs | Florida |
United States | Carolina Rheumatology | Fayetteville | North Carolina |
United States | Integrative Rheumatology of South Texas | Harlingen | Texas |
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 | Southwest Research Group | Mesquite | Texas |
United States | DFW Rheumatology | Red Oak | Texas |
United States | Arthritis and Rheumatic Care Center | South Miami | Florida |
United States | Ohio Arthritis and Osteoporosis Center of Southwest Ohio | Springboro | Ohio |
United States | Arthritis Research and Treatment Center | Stockbridge | Georgia |
United States | Sean Wollaston, MD | Valley Village | California |
United States | Southern Ohio Rheumatology | Wheelersburg | Ohio |
Lead Sponsor | Collaborator |
---|---|
Primus Pharmaceuticals | Illumination Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Numeric Pain Scale | Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7 | Day 1 to Day 7 |
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