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NCT06157177 · ClinicalTrials.gov registry record · Phase 4
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
A Phase 4 study of Lumbar Spinal Stenosis and Sciatica Acute, sponsored by Primus Pharmaceuticals.
- Active
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 19
- Study locations
NCT06157177: Active Phase 4 study of Lumbar Spinal Stenosis and Sciatica Acute, sponsored by Primus Pharmaceuticals.
NCT06157177 is a Phase 4 study of Lumbar Spinal Stenosis and Sciatica Acute that is active but no longer recruiting, run by Primus Pharmaceuticals. The registered enrollment target is 50 participants, below the 667-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (93% lower). The trial reports 19 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06157177, a Phase 4 study of Lumbar Spinal Stenosis and Sciatica Acute, is active but no longer recruiting, sponsored by Primus Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 19
- Study locations
Study 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
Primary Outcome
Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7
Conditions Studied
Interventions
- DRUG Metaxalone 640 mg Oral Tablet
Study Locations (19)
Florida
- Arthritis and Osteoporosis Center - Aventura
- William Sunshine, MD - Boca Raton
- Robert Levin, MD - Clearwater
- 5. CZ Rheumatology - Coral Springs
- 4. Palm Beach Rheumatology and Wellness - Jupiter
- Family Arthritis Center - Loxahatchee Groves
- Arthritis and Rheumatology Center of South Florida - Margate
- Arthritis and Rheumatic Care Center - South Miami
Texas
- Heritage Rheumatology & Arthritis Care - Colleyville
- Integrative Rheumatology of South Texas - Harlingen
- Southwest Research Group - Mesquite
- DFW Rheumatology - Red Oak
Alabama
- East Alabama Arthritis Center - Auburn
California
- Sean Wollaston, MD - Valley Village
Georgia
- Arthritis Research and Treatment Center - Stockbridge
New Mexico
- Jayashree Sinha, MD 1 - Clovis
North Carolina
- Carolina Rheumatology - Fayetteville
Ohio
- Ohio Arthritis and Osteoporosis Center of Southwest Ohio - Springboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2025-11-15 |
| Phase | Phase 4 |
What the registry record for NCT06157177 still lists
NCT06157177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 667-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Metaxalone 640 mg Oral Tablet is the first listed.
NCT06157177 lists 19 locations in 9 states (Florida, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT06157177 about?
NCT06157177 is a clinical study titled "Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.". 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...
What is the current status of trial NCT06157177?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-11-15. Estimated completion is 2025-11-15.
What conditions does trial NCT06157177 study?
This clinical trial studies the following conditions: Lumbar Spinal Stenosis, Sciatica Acute.
What interventions are being tested in trial NCT06157177?
The interventions under investigation include: Metaxalone 640 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT06157177?
This trial is sponsored by Primus Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06157177 being conducted?
This trial has 19 study locations across Alabama, California, Florida, Georgia, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06157177's enrollment target sits among peer trials
50 16th of 18 higher than 3 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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