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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 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.

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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

Conditions Studied

Lumbar Spinal Stenosis Sciatica Acute

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

FieldValue
Enrollment Target 50 participants
Start Date 2023-11-15
Est. Completion 2025-11-15
Phase Phase 4

Sponsor

Primus Pharmaceuticals

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06157177

The ClinicalTrials.gov registry entry for NCT06157177 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 667-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (93% lower). The listed sponsor is Primus Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.

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 reports 19 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.