Melatonin in Patients With Multiple Sclerosis (MS).
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of your current disease modifying therapy (DMT) for multiple sclerosis. You cannot add or change the dose of certain medications like sleep aids, Vitamin D, antidepressants, or stimulants within 30 days before or during the trial.
What data supports the effectiveness of the drug Melatonin, Circadin, Slenyto, PedPRM?
Is melatonin generally safe for human use?
Melatonin, including forms like Circadin and Slenyto, is generally considered safe for human use, with most adverse effects being minor and manageable, such as nausea, dizziness, and headaches. However, there are concerns about its effects on reproductive, cardiovascular, and metabolic systems, especially in children, and potential interactions with other medications. Long-term safety data is limited, so caution is advised, particularly with unlicensed preparations.678910
How does this drug differ from other treatments for circadian rhythm disorders?
Melatonin is unique because it can shift human circadian rhythms by delaying them when taken in the morning and advancing them when taken in the afternoon or early evening. This makes it particularly effective for treating circadian rhythm disorders like jet lag and sleep issues related to shift work.111121314
What is the purpose of this trial?
This trial is testing melatonin supplements in patients with relapsing multiple sclerosis who are already on stable treatments. The goal is to see if melatonin can improve their sleep and overall quality of life. Melatonin has been studied for its potential benefits in improving sleep quality and overall well-being in various conditions, including multiple sclerosis.
Research Team
Kyle Smoot, MD
Principal Investigator
Providence Health & Services
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 3 mg or 5 mg of melatonin daily for one year while continuing their stable dose of oral disease modifying therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Melatonin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Providence Health & Services
Lead Sponsor