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Effacacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Sponsor
Primus Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06157177
Collaborator
Illumination Health (Other)
50
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Metaxalone 640 mg Oral Tablet
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effacacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Actual Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 15, 2025
Anticipated Study Completion Date :
Nov 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active M640

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

Drug: Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Other Names:
  • Skelaxin un-micronized
  • M640
  • metaxalone micronized

    		•
    Placebo Comparator: Placebo

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

    Drug: Metaxalone 640 mg Oral Tablet
    Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
    Other Names:
  • Skelaxin un-micronized
  • M640
  • metaxalone micronized

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of Numeric Pain Scale [Day 1 to Day 7]

      Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    No clinically significant conditions impacting quality or quanity 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 releivers Current use of cimetadine or monoamine oxidase inhibitors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Illumination Health Hoover Alabama United States 35224

    Sponsors and Collaborators

    • Primus Pharmaceuticals
    • Illumination Health

    Investigators

    • Study Chair: James C Lukban, DO, Primus Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Primus Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT06157177
    Other Study ID Numbers:
    • PMMSS-01
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Spinal Stenosis
    Sciatica
    Constriction, Pathologic
    Oxazolidinones
    Metaxalone

    Study Results

    No Results Posted as of Dec 5, 2023