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Tests treatment safety and results for Sciatica Acute
Official title Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
ClinicalTrials.gov ID: NCT06157177
What this study is testing
What is Metaxalone 640 mg Oral Tablet?
Metaxalone 640 mg Oral Tablet is an investigational medicine, being studied as a potential treatment for sciatica acute.
Also referred to as Skelaxin un-micronized, M640.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Current use of other skeletal relaxants
- Current use of other pain relievers
- Current use of cimetidine or monoamine oxidase inhibitors
The study team makes the final eligibility decision.
Where it's taking place
- Auburn, Alabama, United States
- Valley Village, California, United States
- Aventura, Florida, United States
- Boca Raton, Florida, United States
- Clearwater, Florida, United States
- Coral Springs, Florida, United States
- Jupiter, Florida, United States
- Loxahatchee Groves, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Oldsmar, Florida, United States
- South Miami, Florida, United States
- Stockbridge, Georgia, United States
- Sterling Heights, Michigan, United States
- Clovis, New Mexico, United States
- Fayetteville, North Carolina, United States
- Springboro, Ohio, United States
- Crossville, Tennessee, United States
- Colleyville, Texas, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Auburn, Alabama, United States; Valley Village, California, United States; Aventura, Florida, United States; Boca Raton, Florida, United States; Clearwater, Florida, United States; Coral Springs, Florida, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.