Melatonin in Patients With Multiple Sclerosis (MS).

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Treatments: Melatonin

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

• No evidence of significant cognitive or psychiatric disorder

• Able to understand the purpose and risks of the study

• Must be willing to sign an informed consent and follow the protocol requirements

Exclusion Criteria:

• Use of melatonin within 30 days of enrollment

• The addition of any sleep aide or change in dose within 30 days of enrollment or during the trial

• The addition or change in dose of Vitamin D within 30 days of enrollment or during the trial

• Change in DMT during the trial

• Steroid therapy within 30 days of enrollment

• Use of anticoagulation at the time of enrollment and during the trial

• The addition of an antidepressant is not allowed during the study period; if on an antidepressant at screening, the dose must be stable 30 days prior to enrollment and dose changes are prohibited during the study

• The addition or change in dose of any stimulants, including but not limited to, amantadine, armodafinil, methylphenidate, or modafinil within 30 days of enrollment or during the trial