drugset / Trial / NCT03498131
Melatonin in Patients With Multiple Sclerosis (MS).
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-05-09
- Primary completion
- 2022-07-29
- Completion
- 2023-12-11
Publications
- Smoot K, Gervasi-Follmar T, Marginean H, Chen C, Cohan S. Impact of oral melatonin supplementation on urine and serum melatonin concentrations and quality-of-life measures in persons with relapsing multiple sclerosis. Mult Scler Relat Disord. 2024 Oct;90:105799. doi: 10.1016/j.msard.2024.105799. Epub 2024 Aug 3.
- Ghareghani M, Farhadi Z, Rivest S, Zibara K. PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis. Front Immunol. 2022 Mar 9;13:862316. doi: 10.3389/fimmu.2022.862316. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 3 mg | Oral |
| Subject | Melatonin | Small molecule | 5 mg | Oral |