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NCT06157177 Clinical Trial

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Lumbar Spinal Stenosis Clinical Trial

Official title:
Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06157177
Other study ID # PMMSS-01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2025

Study information
Verified date December 2023
Source Primus Pharmaceuticals
Contact S Sodhi
Phone 205-202-0739
Email simi@illumination.health
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date November 15, 2025
Est. primary completion date November 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

Locations
Country Name City State
United States Northern Virginia Center for Arthritis Annandale Virginia
United States East Alabama Arthritis Center Auburn Alabama
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 Jayashree Sinha, MD 1 Clovis New Mexico
United States Heritage Rheumatology & Arthritis Care Colleyville Texas
United States 5. CZ Rheumatology Coral Springs Florida
United States Carolina Rheumatology Fayetteville North Carolina
United States Integrative Rheumatology of South Texas Harlingen Texas
United States 4. Palm Beach Rheumatology and Wellness Jupiter Florida
United States Family Arthritis Center Loxahatchee Groves Florida
United States Arthritis and Rheumatology Center of South Florida Margate Florida
United States Southwest Research Group Mesquite Texas
United States DFW Rheumatology Red Oak Texas
United States Arthritis and Rheumatic Care Center South Miami Florida
United States Ohio Arthritis and Osteoporosis Center of Southwest Ohio Springboro Ohio
United States Arthritis Research and Treatment Center Stockbridge Georgia
United States Sean Wollaston, MD Valley Village California
United States Southern Ohio Rheumatology Wheelersburg Ohio

Sponsors (2)
Lead Sponsor Collaborator
Primus Pharmaceuticals Illumination Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Numeric Pain Scale Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7 Day 1 to Day 7
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