Metaxalone vs Tizanidine for Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two medications, metaxalone and tizanidine, affect cognitive impairment. Researchers are testing both drugs to determine if they improve thinking and memory when taken with a high-fat meal. Participants will take each medication at different times, attending four visits for safety checks and discussions. The trial seeks medically healthy individuals who weigh at least 120 pounds and can consume a high-fat meal. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that affect the sleep-wake cycle, cimetidine, certain antidepressants, and certain antibiotics. If you are using any of these, you would need to stop before participating.
What is the safety track record for these treatments?
Research shows that metaxalone, a muscle relaxant, is usually well-tolerated. However, in rare cases, it can cause hemolytic anemia, where red blood cells are destroyed faster than they are produced. It may also cause daytime drowsiness, especially when combined with other medications that slow the central nervous system.
For tizanidine, studies suggest it is safe to use but may increase the risk of certain injuries in older adults. It has effectively reduced muscle stiffness, particularly in conditions like traumatic brain injuries and strokes.
Both treatments have approval for other uses, indicating a level of established safety. However, discussing possible side effects with a doctor before joining a trial is important.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the treatments metaxalone and tizanidine for cognitive impairment because they offer potential new approaches compared to typical medications such as cholinesterase inhibitors and memantine. Unlike standard options, which primarily work by boosting neurotransmitters, metaxalone and tizanidine may influence cognitive function through muscle relaxation and reducing muscle spasticity, possibly impacting neural pathways differently. This unique action could provide an alternative benefit, especially for patients who don't respond well to current therapies. Additionally, the micronized form of metaxalone might offer enhanced absorption and efficacy, setting it apart from traditional formulations.
What evidence suggests that this trial's treatments could be effective for cognitive impairment?
This trial will compare metaxalone and tizanidine for their effects on cognitive impairment. Research shows that metaxalone, a muscle relaxant, acts on the brain and spinal cord. It often relieves muscle pain but typically does not improve thinking or memory. Although the exact mechanism of metaxalone remains unclear, it eases muscle tightness. In this trial, some participants will receive metaxalone.
Other participants will receive tizanidine, another muscle relaxant. Studies indicate that tizanidine can help with muscle spasms and is sometimes used for conditions like multiple sclerosis. Neither drug has been proven to treat cognitive issues, so their effectiveness in this area is uncertain. These medications are generally well-tolerated, but they can cause side effects like drowsiness.23467Who Is on the Research Team?
J C Lukban, DO
Principal Investigator
Sponsor GmbH
Are You a Good Fit for This Trial?
This trial is for individuals who experience muscle weakness (hypotonia) and may have cognitive impairments. Participants should be able to attend four visits, take the study drug after a high-fat meal, and discuss their health status at each visit.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo cognitive and driving simulation tests
Treatment
Participants receive single doses of study drugs and undergo repeated cognitive and driving tests
Follow-up
End of study safety assessments and discharge instructions
What Are the Treatments Tested in This Trial?
Interventions
- Metaxalone 640 mg (M640)
Metaxalone 640 mg (M640) is already approved in United States for the following indications:
- Acute, painful musculoskeletal conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Primus Pharmaceuticals
Lead Sponsor
Sun Valley Arthritis Center
Collaborator