ACTIVE_NOT_RECRUITING

Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

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Conditions

Sciatica AcuteLumbar Spinal Stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica

Quick Facts

Study Start:2023-11-15
Study Completion:2025-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06157177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No clinically significant conditions impacting quality or quantity of pain
  2. * Baseline Numeric Pain Scale ≥ 6
  3. * Capable of answering text or email survey reminders
  4. * Low back pain with or without sciatica
  1. * Current use of other skeletal relaxants
  2. * Current use of other pain relievers
  3. * Current use of cimetidine or monoamine oxidase inhibitors

Contacts and Locations

Principal Investigator

S Sodhi
STUDY_DIRECTOR
Illumination Health

Study Locations (Sites)

East Alabama Arthritis Center
Auburn, Alabama, 36830
United States
Sean Wollaston, MD
Valley Village, California, 91607
United States
Arthritis and Osteoporosis Center
Aventura, Florida, 33180
United States
William Sunshine, MD
Boca Raton, Florida, 33431
United States
Robert Levin, MD
Clearwater, Florida, 33765
United States
5. CZ Rheumatology
Coral Springs, Florida, 33065
United States
4. Palm Beach Rheumatology and Wellness
Jupiter, Florida, 33458
United States
Family Arthritis Center
Loxahatchee Groves, Florida, 33458
United States
Arthritis and Rheumatology Center of South Florida
Margate, Florida, 33063
United States
Arthritis and Rheumatic Care Center
South Miami, Florida, 33143
United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, 30281
United States
Jayashree Sinha, MD 1
Clovis, New Mexico, 88101
United States
Carolina Rheumatology
Fayetteville, North Carolina, 28304
United States
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
Springboro, Ohio, 45066
United States
Heritage Rheumatology & Arthritis Care
Colleyville, Texas, 76034
United States
Integrative Rheumatology of South Texas
Harlingen, Texas, 78550
United States
Southwest Research Group
Mesquite, Texas, 75150
United States
DFW Rheumatology
Red Oak, Texas, 75154
United States
Northern Virginia Center for Arthritis
Annandale, Virginia, 22003
United States

Collaborators and Investigators

Sponsor: Primus Pharmaceuticals

  • S Sodhi, STUDY_DIRECTOR, Illumination Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15
Study Completion Date2025-11-15

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2025-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Sciatica Acute
  • Lumbar Spinal Stenosis