Status:
ACTIVE_NOT_RECRUITING
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Lead Sponsor:
Primus Pharmaceuticals
Collaborating Sponsors:
Illumination Health
Conditions:
Sciatica Acute
Lumbar Spinal Stenosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 l...
Detailed Description
Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sci...
Eligibility Criteria
Inclusion
- 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
- Current use of other skeletal relaxants
- Current use of other pain relievers
- Current use of cimetidine or monoamine oxidase inhibitors
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06157177
Start Date
November 15 2023
End Date
November 15 2025
Last Update
August 7 2025
Active Locations (19)
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1
East Alabama Arthritis Center
Auburn, Alabama, United States, 36830
2
Sean Wollaston, MD
Valley Village, California, United States, 91607
3
Arthritis and Osteoporosis Center
Aventura, Florida, United States, 33180
4
William Sunshine, MD
Boca Raton, Florida, United States, 33431