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New twist on old muscle relaxant aims to ease sciatica pain in days

NCT ID NCT06157177

Symptom relief Sponsor: Primus Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a modified version of the muscle relaxant metaxalone (640 mg) can reduce low back and leg pain in people with acute sciatica or spinal stenosis. Fifty adults aged 18 to 80 with new-onset pain will take either the drug or a placebo for 7 days. Researchers will measure pain levels, sleep quality, and physical activity before and after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metaxalone 640 mg (muscle relaxant)
What this could lead to
If it works, this could offer a new option for quickly easing acute back and leg pain caused by spinal stenosis or sciatica.
What could go wrong
This is a small, early-phase trial with only 50 people. The drug may not prove better than a placebo, and side effects like drowsiness or dizziness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lumbar spinal stenosis sciatica spinal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lumbar spinal stenosis Sciatica acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 4. Palm Beach Rheumatology and Wellness

    ACTIVE_NOT_RECRUITING

    Jupiter, Florida, 33458, United States

  • 5. CZ Rheumatology

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Arthritis Research and Treatment Center

    ACTIVE_NOT_RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Arthritis and Osteoporosis Center

    ACTIVE_NOT_RECRUITING

    Aventura, Florida, 33180, United States

  • Arthritis and Osteoporosis Treatment and ResearchCenter

    RECRUITING

    Miami, Florida, 33180, United States

  • Arthritis and Rheumatic Care Center

    ACTIVE_NOT_RECRUITING

    South Miami, Florida, 33143, United States

  • Arthritis and Rheumatology Center of MI

    RECRUITING

    Sterling Heights, Michigan, 48310, United States

  • Arthritis and Rheumatology Center of South Florida

    ACTIVE_NOT_RECRUITING

    Margate, Florida, 33063, United States

  • Bay Area Rheumatology

    RECRUITING

    Oldsmar, Florida, 34677, United States

  • CZ Rheumatology

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Carolina Rheumatology

    ACTIVE_NOT_RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • Cumberland Rheumatology

    RECRUITING

    Crossville, Tennessee, 38555, United States

  • DFW Rheumatology

    ACTIVE_NOT_RECRUITING

    Red Oak, Texas, 75154, United States

  • East Alabama Arthritis Center

    ACTIVE_NOT_RECRUITING

    Auburn, Alabama, 36830, United States

  • Family Arthritis Center

    ACTIVE_NOT_RECRUITING

    Loxahatchee Groves, Florida, 33458, United States

  • Heritage Rheumatology & Arthritis Care

    RECRUITING

    Colleyville, Texas, 76034, United States

  • Integrative Rheumatology of South Texas

    ACTIVE_NOT_RECRUITING

    Harlingen, Texas, 78550, United States

  • Jayashree Sinha, MD 1

    ACTIVE_NOT_RECRUITING

    Clovis, New Mexico, 88101, United States

  • Northern Virginia Center for Arthritis

    ACTIVE_NOT_RECRUITING

    Annandale, Virginia, 22003, United States

  • Ohio Arthritis and Osteoporosis Center of Southwest Ohio

    ACTIVE_NOT_RECRUITING

    Springboro, Ohio, 45066, United States

  • Robert Levin, MD

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Sean Wollaston, MD

    ACTIVE_NOT_RECRUITING

    Valley Village, California, 91607, United States

  • Southwest Research Group

    ACTIVE_NOT_RECRUITING

    Mesquite, Texas, 75150, United States

  • William Sunshine, MD

    ACTIVE_NOT_RECRUITING

    Boca Raton, Florida, 33431, United States

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