Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Phase 4

Recruiting

• Conditions: Sciatica Acute; Lumbar Spinal Stenosis
• Interventions: Drug: Metaxalone 640 mg Oral Tablet

• Registration Number: NCT06157177
• Lead Sponsor: Primus Pharmaceuticals

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 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

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 sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Status Verified: 2023-12
• Study First Posted: 2023-12-05
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active M640	Metaxalone 640 mg Oral Tablet	Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days
Placebo	Metaxalone 640 mg Oral Tablet	Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Primary Outcome Measures

Name	Time	Method
Change of Numeric Pain Scale	Day 1 to Day 7	Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7

Trial Locations

Locations (19)

Jayashree Sinha, MD 1; 🇺🇸 Clovis, New Mexico, United States

East Alabama Arthritis Center; 🇺🇸 Auburn, Alabama, United States

Sean Wollaston, MD; 🇺🇸 Valley Village, California, 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

5. CZ Rheumatology; 🇺🇸 Coral Springs, Florida, United States

4. Palm Beach Rheumatology and Wellness; 🇺🇸 Jupiter, Florida, United States

Arthritis Research and Treatment Center; 🇺🇸 Stockbridge, Georgia, United States

Integrative Rheumatology of South Texas; 🇺🇸 Harlingen, Texas, United States

Southwest Research Group; 🇺🇸 Mesquite, Texas, United States

Family Arthritis Center; 🇺🇸 Loxahatchee Groves, Florida, United States

Arthritis and Rheumatology Center of South Florida; 🇺🇸 Margate, Florida, United States

Arthritis and Rheumatic Care Center; 🇺🇸 South Miami, Florida, United States

Carolina Rheumatology; 🇺🇸 Fayetteville, North Carolina, United States

Ohio Arthritis and Osteoporosis Center of Southwest Ohio; 🇺🇸 Springboro, Ohio, United States

Heritage Rheumatology & Arthritis Care; 🇺🇸 Colleyville, Texas, United States

DFW Rheumatology; 🇺🇸 Red Oak, Texas, United States

Northern Virginia Center for Arthritis; 🇺🇸 Annandale, Virginia, United States