30 Participants Needed

Melatonin in Patients With Multiple Sclerosis (MS).

CC
TG
Overseen ByTiffany Gervasi, MPH
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Providence Health & Services
Must be taking: Oral DMTs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that melatonin can help adjust the body's internal clock, improving sleep and alertness in people with circadian rhythm disorders like jet lag and non-24-hour sleep-wake disorder, especially in blind individuals.12345

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

KS

Kyle Smoot, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

Inclusion Criteria

Male and female subjects with relapsing forms of MS who have been on a stable dose of dimethyl fumarate, fingolimod, teriflunomide, diroximel fumarate, siponimod, or ozanimod for 6 months or longer
Confirmed diagnosis of Relapsing MS
Women of childbearing potential must employ proven methods to prevent pregnancy during the course of the trial; the acceptable method will be left to the judgment of the investigator Not pregnant or lactating
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 months
Visits at Baseline, Month 3, Month 6, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Melatonin
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 5 mg MelatoninExperimental Treatment1 Intervention
Subjects will receive 5 mg melatonin once a day.
Group II: 3 mg MelatoninExperimental Treatment1 Intervention
Subjects will receive 3 mg melatonin once a day.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials
131
Recruited
827,000+

Findings from Research

Melatonin can effectively phase-shift circadian rhythms and improve sleep in totally blind individuals with non-24 hour sleep/wake disorder, especially when administered at the right time relative to their circadian phase.
Light exposure, particularly short wavelength light, can suppress melatonin production and influence circadian rhythms, indicating that optimizing light's spectral composition may enhance its effectiveness in regulating sleep patterns.
Optimization of light and melatonin to phase-shift human circadian rhythms.Skene, DJ.[2019]
Melatonin effectively phase shifts circadian rhythms, making it a useful treatment for sleep disorders related to circadian misalignment, such as jet lag and shift work.
In specific conditions like delayed sleep phase syndrome (DSPS) and non-24-hour sleep-wake disorder, melatonin has been shown to advance sleep onset and improve overall sleep quality compared to placebo.
Use of melatonin in the treatment of phase shift and sleep disorders.Skene, DJ., Lockley, SW., Arendt, J.[2019]
In a postmarketing surveillance study of 653 patients aged 55 and older, prolonged-release melatonin (PRM) significantly improved sleep quality from an average score of 4.2 to 2.6 and morning alertness from 4.0 to 2.5 over three weeks of treatment.
PRM demonstrated a low incidence of rebound insomnia (3.2% early withdrawal, 2.0% late withdrawal) and was well tolerated, with minimal adverse effects, suggesting it is a safe and effective alternative to traditional hypnotics for managing insomnia.
Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin.Hajak, G., Lemme, K., Zisapel, N.[2021]

References

Melatonin and the pineal gland: influence on mammalian seasonal and circadian physiology. [2022]
Advances in the pharmacological management of non-24-h sleep-wake disorder. [2021]
Melatonin phase advances circadian rhythm. [2019]
Optimization of light and melatonin to phase-shift human circadian rhythms. [2019]
Use of melatonin in the treatment of phase shift and sleep disorders. [2019]
Lasting treatment effects in a postmarketing surveillance study of prolonged-release melatonin. [2021]
Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial. [2022]
Treatment of circadian rhythm disorders--melatonin. [2019]
Adverse events associated with oral administration of melatonin: A critical systematic review of clinical evidence. [2019]
Potential safety issues in the use of the hormone melatonin in paediatrics. [2015]
The Mel1a melatonin receptor gene is expressed in human suprachiasmatic nuclei. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Genetic control of melatonin synthesis in the pineal gland of the mouse. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Melatonin: characteristics, concerns, and prospects. [2013]
Melatonin shifts human circadian rhythms according to a phase-response curve. [2019]
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