NCT06157177

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

November 27, 2023

Last Update Submit

August 5, 2025

Conditions

Sciatica AcuteLumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Active M640

ACTIVE COMPARATOR

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

Drug: Metaxalone 640 mg Oral Tablet

Placebo

PLACEBO COMPARATOR

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

Drug: Metaxalone 640 mg Oral Tablet

Interventions

Metaxalone 640 mg Oral TabletDRUG

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

Also known as: Skelaxin un-micronized, M640, metaxalone micronized
Active M640Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current use of other skeletal relaxants
  • Current use of other pain relievers
  • Current use of cimetidine or monoamine oxidase inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

East Alabama Arthritis Center

Auburn, Alabama, 36830, United States

Location

Sean Wollaston, MD

Valley Village, California, 91607, United States

Location

Arthritis and Osteoporosis Center

Aventura, Florida, 33180, United States

Location

William Sunshine, MD

Boca Raton, Florida, 33431, United States

Location

Robert Levin, MD

Clearwater, Florida, 33765, United States

Location

5. CZ Rheumatology

Coral Springs, Florida, 33065, United States

Location

4. Palm Beach Rheumatology and Wellness

Jupiter, Florida, 33458, United States

Location

Family Arthritis Center

Loxahatchee Groves, Florida, 33458, United States

Location

Arthritis and Rheumatology Center of South Florida

Margate, Florida, 33063, United States

Location

Arthritis and Rheumatic Care Center

South Miami, Florida, 33143, United States

Location

Arthritis Research and Treatment Center

Stockbridge, Georgia, 30281, United States

Location

Jayashree Sinha, MD 1

Clovis, New Mexico, 88101, United States

Location

Carolina Rheumatology

Fayetteville, North Carolina, 28304, United States

Location

Ohio Arthritis and Osteoporosis Center of Southwest Ohio

Springboro, Ohio, 45066, United States

Location

Heritage Rheumatology & Arthritis Care

Colleyville, Texas, 76034, United States

Location

Integrative Rheumatology of South Texas

Harlingen, Texas, 78550, United States

Location

Southwest Research Group

Mesquite, Texas, 75150, United States

Location

DFW Rheumatology

Red Oak, Texas, 75154, United States

Location

Northern Virginia Center for Arthritis

Annandale, Virginia, 22003, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

metaxaloneTablets

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • S Sodhi

    Illumination Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 5, 2023

Study Start

November 15, 2023

Primary Completion

November 15, 2025

Study Completion

November 15, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(19)