Clinical trial NCT06157177: Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Official title: Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sciatica Acute
Lumbar Spinal Stenosis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Illumination Health
First posted: 2023-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Numeric Pain Scale
timeFrame: Day 1 to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: East Alabama Arthritis Center
state: Alabama
city: Valley Village
country: United States
facility: Sean Wollaston, MD
state: California
city: Aventura
country: United States
facility: Arthritis and Osteoporosis Center
state: Florida
city: Boca Raton
country: United States
facility: William Sunshine, MD
state: Florida
city: Clearwater
country: United States
facility: Robert Levin, MD
state: Florida
city: Coral Springs
country: United States
facility: 5. CZ Rheumatology
state: Florida
city: Jupiter
country: United States
facility: 4. Palm Beach Rheumatology and Wellness
state: Florida
city: Loxahatchee Groves
country: United States
facility: Family Arthritis Center
state: Florida
city: Margate
country: United States
facility: Arthritis and Rheumatology Center of South Florida
state: Florida
city: South Miami
country: United States
facility: Arthritis and Rheumatic Care Center
state: Florida
city: Stockbridge
country: United States
facility: Arthritis Research and Treatment Center
state: Georgia
city: Clovis
country: United States
facility: Jayashree Sinha, MD 1
state: New Mexico
city: Fayetteville
country: United States
facility: Carolina Rheumatology
state: North Carolina
city: Springboro
country: United States
facility: Ohio Arthritis and Osteoporosis Center of Southwest Ohio
state: Ohio
city: Colleyville
country: United States
facility: Heritage Rheumatology & Arthritis Care
state: Texas
city: Harlingen
country: United States
facility: Integrative Rheumatology of South Texas
state: Texas
city: Mesquite
country: United States
facility: Southwest Research Group
state: Texas
city: Red Oak
country: United States
facility: DFW Rheumatology
state: Texas
city: Annandale
country: United States
facility: Northern Virginia Center for Arthritis
state: Virginia
Study officials:
affiliation: Illumination Health
name: S Sodhi
role: STUDY_DIRECTOR
References: