Metaxalone for Lower Back Pain

Not currently recruiting at 20 trial locations

Overseen By S Sodhi

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Primus Pharmaceuticals

Must not be taking: Skeletal relaxants, Pain relievers, Cimetidine, MAO inhibitors

Disqualifiers: Clinically significant conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a modified version of metaxalone, a muscle relaxant, can reduce low back and leg pain. Participants will be divided into two groups: one will take metaxalone, and the other will take a placebo, which resembles the real medicine but contains no active ingredients. The study will assess the treatment's effects on pain levels, physical activity, and sleep. This trial suits individuals who have recently developed low back pain or sciatica and are not using muscle relaxants or certain other medications. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current skeletal relaxants, pain relievers, cimetidine, or monoamine oxidase inhibitors to participate in this trial.

What is the safety track record for Metaxalone?

Research has shown that metaxalone is generally safe for use. This medication often relaxes muscles and relieves pain from temporary muscle or bone issues. Studies have found that dizziness and drowsiness are the most common side effects. Some individuals might also experience headaches or an upset stomach, though these are less common.

Metaxalone is widely prescribed, indicating it is considered safe for many. While information on serious side effects is limited, available evidence suggests they are rare. Prospective trial participants might find these findings useful. Always consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about metaxalone for lower back pain because it offers a potentially faster and safer alternative to current treatments. Unlike standard medications like NSAIDs or opioids, which can take hours to days for relief and have significant side effects, metaxalone is designed to be taken every six hours, potentially providing quicker pain relief. Additionally, it is a muscle relaxant that may have fewer side effects compared to opioids, which are often associated with risks of dependency and other serious side effects. This makes metaxalone a promising option for those seeking effective pain management with potentially fewer risks.

What is the effectiveness track record for Metaxalone in treating lower back pain?

Research has shown that metaxalone, a muscle relaxant, often helps with muscle pain, such as that from straining the lower back. Studies have found that it can relax muscles, potentially reducing pain and discomfort. However, when tested with common pain relievers, metaxalone did not always outperform a placebo in improving pain and function for individuals with sudden low back pain. Despite these mixed results, some people still find metaxalone helpful for easing muscle-related discomfort. This trial will compare an active treatment arm using a new version of metaxalone with a placebo arm to determine if this new version can provide better relief for low back and leg pain. ^{6 7 8 9 10}

Who Is on the Research Team?

S Sodhi

Principal Investigator

Illumination Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Baseline Numeric Pain Scale ≥ 6

I don't have conditions that worsen my pain significantly.

I can respond to surveys via text or email.

Exclusion Criteria

I am currently using pain relievers.

I am currently taking cimetidine or monoamine oxidase inhibitors.

I am currently taking medication for muscle relaxation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metaxalone 640 mg or placebo every 6 hours for 7 days

1 week

1 visit (in-person) on Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person) on Day 7

What Are the Treatments Tested in This Trial?

Interventions

• Metaxalone

Trial Overview

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.

How Is the Trial Designed?

Group I: Active M640 Active Control 1 Intervention

Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days

Group II: Placebo Placebo Group 1 Intervention

Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Metaxalone is already approved in United States for the following indications:

Approved in United States as Metaxalone for:

• Acute, painful musculoskeletal conditions

Who Is Running the Clinical Trial?

Primus Pharmaceuticals

Lead Sponsor

Trials

22

Recruited

2,400+

Illumination Health

Collaborator

Trials

3

Recruited

1,300+

Published Research Related to This Trial

A case study indicates that metaxalone, a muscle relaxant, was the sole cause of death in a relatively young individual, highlighting its potential risks despite being rarely associated with fatalities.

Blood concentration levels of metaxalone were significantly high at the time of hospital admission (37.4 mcg/mL) and postmortem, suggesting that even at these levels, the drug's safety profile may need further evaluation, especially considering the blood-to-plasma ratio of 1.4.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rare fatality attributed solely to metaxalone. Curtis, B., Jenkins, C., Wiens, AL.[2015]

A new reversed phase ultra performance liquid chromatography (RP-UPLC) method was developed to accurately measure metaxalone in pharmaceutical products, effectively separating it from known and unknown impurities within 6 minutes.

Metaxalone showed significant degradation under basic stress conditions but remained stable under acid, hydrolytic, thermal, and photolytic conditions, demonstrating the method's ability to indicate the drug's stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Stability-Indicating RP-UPLC Method for Rapid Determination of Metaxalone and its Degradation Products in Solid Oral Dosage Form. Trivedi, RK., Patel, MC.[2021]

Metaxalone demonstrated an ability to inhibit the proliferation and promote the death of inflammatory macrophages in vitro, suggesting a potential mechanism for its effects on muscle pain.

The study found that metaxalone reduced the production of inflammatory cytokines and decreased levels of key inflammatory markers, indicating its role in suppressing inflammation at the cellular level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metaxalone Suppresses Production of Inflammatory Cytokines Associated with Painful Conditions in Mouse Macrophages RAW264.7 Cells in Vitro: Synergistic Effect with β-caryophyllene. Yamaguchi, M., Levy, RM.[2021]

A new high-throughput tandem mass spectroscopic method was developed to accurately measure metaxalone levels in human plasma, ensuring precise and reliable results for clinical studies.

The method demonstrated excellent stability and recovery rates, with no interference from other substances, making it suitable for evaluating metaxalone's effectiveness in pain relief across various plasma conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metaxalone estimation in biological matrix using high-throughput LC-MS/MS bioanalytical method. Goswami, D., Saha, A., Gurule, S., et al.[2013]

A fatal overdose case involving metaxalone revealed high concentrations of the drug (19 mg/L in aortic blood) alongside other substances, indicating potential risks associated with its use, especially in combination with other medications.

The study highlights the limited information on metaxalone toxicity, as the pathologist attributed the cause of death primarily to hydrocodone intoxication, suggesting that while metaxalone can be present in overdose cases, its direct role in fatalities may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metaxalone (Skelaxin)-related death. Poklis, JL., Ropero-Miller, JD., Garside, D., et al.[2019]

In a study of 142 adults who ingested metaxalone, higher doses (over 2400 mg) were linked to more serious medical outcomes, with 100% of these cases requiring management at health care facilities.

The most common adverse effects included drowsiness, tachycardia, and agitation, with 50.8% of cases resulting in 'no effect', indicating that while some ingestions can be serious, many do not lead to severe outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult metaxalone ingestions reported to Texas poison control centers, 2000-2006. Forrester, MB.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6756993/

A randomized, placebo controlled trial of ibuprofen ...

Conclusion: Adding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo + ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0736467921008398

The Relative Efficacy of Seven Skeletal Muscle Relaxants. ...

Among patients in the ED with acute LBP treated with a nonsteroidal anti-inflammatory drug, SMRs do not improve outcomes more than placebo. Neither age, sex, ...

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go.drugbank.com

go.drugbank.com/drugs/DB00660

Metaxalone: Uses, Interactions, Mechanism of Action

Metaxalone is a moderate to strong muscle relaxant used in the symptomatic treatment of musculoskeletal pain caused by strains, sprains, and other ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2823750

Long-Term Use of Muscle Relaxant Medications for ...

This systematic review evaluates the efficacy and safety of long-term use of skeletal muscle relaxants for low back pain, fibromyalgia, ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2015/022503Orig1s000MedR.pdf

022503Orig1s000 - accessdata.fda.gov

metaxalone results in approximately 25% lower exposure), but bioequivalence under fed ... clinical trials of acute musculoskeletal low back pain.

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/metaxalone-oral-route/description/drg-20071948

Metaxalone (oral route) - Side effects & dosage

Metaxalone is used to help relax the muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions.

7.

webmd.com

webmd.com/drugs/2/drug-7898/metaxalone-oral/details

Metaxalone (Skelaxin) - Uses, Side Effects, and More

It seems to relax muscles by affecting nerve activity in the spinal cord. Common side effects include dizziness and drowsiness.

8.

goodrx.com

goodrx.com/metaxalone/what-is?srsltid=AfmBOooyTp8waQic9EIWmF2DWuFtrZPZiUZzMOeIVqcEkLJ2OpVrNgfV

Metaxalone: Uses, Side Effects, Dosage & More

This medication is thought to relieve muscle pain by relaxing your nervous system in the brain. Metaxalone is typically taken by mouth three or four times a day ...

9.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK548838/

Metaxalone - LiverTox - NCBI Bookshelf

Sparse data are available regarding metaxalone safety. Side effects are not common, but can include drowsiness, dizziness, headache, nausea, ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15530999/

Commonly used muscle relaxant therapies for acute low ...

Carisoprodol, cyclobenzaprine hydrochloride, and metaxalone represented >45% of all such prescriptions. Cochrane Library, MEDLINE, and EMBASE databases were ...