Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
East Alabama Arthritis Center
ACTIVE_NOT_RECRUITING
Auburn
California
Sean Wollaston, MD
ACTIVE_NOT_RECRUITING
Valley Village
Florida
Arthritis and Osteoporosis Center
ACTIVE_NOT_RECRUITING
Aventura
William Sunshine, MD
ACTIVE_NOT_RECRUITING
Boca Raton
Robert Levin, MD
RECRUITING
Clearwater
5. CZ Rheumatology
RECRUITING
Coral Springs
4. Palm Beach Rheumatology and Wellness
ACTIVE_NOT_RECRUITING
Jupiter
Family Arthritis Center
ACTIVE_NOT_RECRUITING
Loxahatchee Groves
Arthritis and Rheumatology Center of South Florida
ACTIVE_NOT_RECRUITING
Margate
Arthritis and Osteoporosis Treatment and ResearchCenter
RECRUITING
Miami
CZ Rheumatology
RECRUITING
Miami Beach
Bay Area Rheumatology
RECRUITING
Oldsmar
Arthritis and Rheumatic Care Center
ACTIVE_NOT_RECRUITING
South Miami
Georgia
Arthritis Research and Treatment Center
ACTIVE_NOT_RECRUITING
Stockbridge
Michigan
Arthritis and Rheumatology Center of MI
RECRUITING
Sterling Heights
North Carolina
Carolina Rheumatology
ACTIVE_NOT_RECRUITING
Fayetteville
New Mexico
Jayashree Sinha, MD 1
ACTIVE_NOT_RECRUITING
Clovis
Ohio
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
ACTIVE_NOT_RECRUITING
Springboro
Tennessee
Cumberland Rheumatology
RECRUITING
Crossville
Texas
Heritage Rheumatology & Arthritis Care
RECRUITING
Colleyville
Integrative Rheumatology of South Texas
ACTIVE_NOT_RECRUITING
Harlingen
Southwest Research Group
ACTIVE_NOT_RECRUITING
Mesquite
DFW Rheumatology
ACTIVE_NOT_RECRUITING
Red Oak
Virginia
Northern Virginia Center for Arthritis
ACTIVE_NOT_RECRUITING
Annandale
Contact Information
Primary
S Sodhi
simi@illumination.health
205-202-0739
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 50
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Primus Pharmaceuticals
Collaborators: Illumination Health