Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPrimus Pharmaceuticals
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Current use of other skeletal relaxants
Current use of other pain relievers
Current use of cimetidine or monoamine oxidase inhibitors
Trial design
Design model
Parallel
Treatments tested in this trial
Metaxalone 640 mg Oral Tablet
DrugMetaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active M640Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Day 1 to Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Primus Pharmaceuticals
Lead sponsor
Illumination Health
Collaborator
Source ClinicalTrials.gov