Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metaxalone 640 mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Sciatica Acute, Lumbar Spinal Stenosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
Overview
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
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.
Interventions
- Drug Metaxalone 640 mg Oral Tablet
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Primary outcome measures
- Change of Numeric Pain Scale [Time frame: Day 1 to Day 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- East Alabama Arthritis Center — Auburn
- Sean Wollaston, MD — Valley Village
- Arthritis and Osteoporosis Center — Aventura
- William Sunshine, MD — Boca Raton
- Robert Levin, MD — Clearwater
- 5. CZ Rheumatology — Coral Springs
- 4. Palm Beach Rheumatology and Wellness — Jupiter
- Family Arthritis Center — Loxahatchee Groves
- … and 16 more centers
Identifiers
NCT: NCT06157177 · PMMSS-01