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Muscle Relaxant

Metaxalone for Lower Back Pain

Phase 4
Recruiting
Research Sponsored by Primus Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 7
Awards & highlights

Study Summary

This trial will test if a modified version of metaxalone 640 mg helps reduce back and leg pain in 18-80 year olds. People will report on pain, physical activity and sleep before and after treatment.

Who is the study for?
This trial is for adults aged 18-80 with new low back or leg pain, who can respond to surveys. They must have a pain score of at least 6 and no other conditions affecting their pain. People using muscle relaxants, other pain meds, cimetidine, or MAO inhibitors cannot join.Check my eligibility
What is being tested?
The study tests if modified metaxalone (a muscle relaxant) helps reduce acute lower back and leg pain compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and will report on their pain and its impact over a week.See study design
What are the potential side effects?
While not specified here, common side effects of metaxalone may include dizziness, nausea, vomiting, headache, drowsiness; however individual experiences with side effects can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Numeric Pain Scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active M640Active Control1 Intervention
Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days
Group II: PlaceboPlacebo Group1 Intervention
Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Find a Location

Who is running the clinical trial?

Primus PharmaceuticalsLead Sponsor
21 Previous Clinical Trials
2,306 Total Patients Enrolled
Illumination HealthNETWORK
1 Previous Clinical Trials
160 Total Patients Enrolled
S SodhiStudy DirectorIllumination Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person meet to become an eligible participant in this research trial?

"Individuals aged between 18 and 80 with sciatica can apply to be part of this research, providing the total participant count has not exceeded 50 yet."

Answered by AI

What is the approximate size of the cohort involved in this medical trial?

"True, the details published on clinicaltrials.gov reveal that this medical trial is currently enrolling patients to take part in the experiment. It was first posted on November 15th 2023 and last edited on November 27th of the same year. A total of 50 participants are being sought from 1 location."

Answered by AI

Does this clinical research extend to individuals of advanced age?

"Qualified participants for this trial are aged 18 to 80 years old. A further 21 studies cater exclusively to minors, while 267 trials focus on older individuals over the age of 65."

Answered by AI

Can you provide insight into the safety of Active M640 for humans?

"Our team at Power has determined that Active M640 is safe to a degree of 3, reflecting the fact that this medication has been approved by Phase 4 clinical trials."

Answered by AI

Are there any vacancies left for prospective participants in this clinical trial?

"Affirmative. Data accessible on clinicaltrials.gov validates that this study, which was initially posted on November 15th 2023, is currently enrolling volunteers. 50 test subjects must be enrolled from a single healthcare facility."

Answered by AI

Who else is applying?

What site did they apply to?
Illumination Health
Arthritis and Osteoporosis Center
Arthritis and Rheumatic Care Center
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

dolores en huesos constantes.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
2023. "Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157177.
All > High Point > Greensboro
~33 spots leftby Nov 2025
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