Recruiting

Metaxalone

Sponsor:

Primus Pharmaceuticals

Code:

NCT06157177

Conditions

Sciatica Acute

Lumbar Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Metaxalone 640 mg Oral Tablet

Study Details

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

Conditions

Sciatica Acute

Lumbar Spinal Stenosis

Study ID

NCT06157177

Start date

Nov 15, 2023

Status verified date

Aug, 2025

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active M640

Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days

placebo comparator: Placebo

Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Interventions

Metaxalone 640 mg Oral Tablet

Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.

Primary outcome measure

  • Change of Numeric Pain Scale [ Time Frame: Day 1 to Day 7 ]

Central Contacts and Locations

Central contacts

S Sodhi

205-202-0739simi@illumination.health

Locations

Robert Levin, MD

Recruiting

Clearwater, Florida, United States, 33765

Contacts

simi@illumination.health

5. CZ Rheumatology

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

simi@illumination.health

Arthritis and Osteoporosis Treatment and ResearchCenter

Recruiting

Miami, Florida, United States, 33180

Contacts

George Munoz, MD

simi@illumination.health

CZ Rheumatology

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Conrad Ziembinski, DO

simi@illumination.health

Bay Area Rheumatology

Recruiting

Oldsmar, Florida, United States, 34677

Contacts

Rodney Daniel,, MD

simi@illumination.health

Arthritis and Rheumatology Center of MI

Recruiting

Sterling Heights, Michigan, United States, 48310

Contacts

Srijana Bakshi, MD

simi@illumination.health

Cumberland Rheumatology

Recruiting

Crossville, Tennessee, United States, 38555

Contacts

Sivalingam Kanagasegar, MD

simi@illumination.health

Heritage Rheumatology & Arthritis Care

Recruiting

Colleyville, Texas, United States, 76034

Contacts

simi@illumination.health

More Information

Sponsor

Primus Pharmaceuticals

Last update posted

May 12, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Primus Pharmaceuticals on 2026-05-12.