NCT03498131CompletedEarly phase 1
Melatonin in Patients With Multiple Sclerosis (MS).
Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS)
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 6 Apr 2018
- Start date
- 9 May 2018
- Primary completion date
- 29 Jul 2022
- Lead sponsor
- Providence Health & Services
- Diseases
- Multiple sclerosis
- NCT number
- NCT03498131
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 30
- From 9 May 2018 to the primary completion date, 29 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Steroid therapy within 30 days of enrollment
- 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
Other
- 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
- Use of anticoagulation at the time of enrollment and during the trial
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence MS Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
Related publications
- 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 · PMID 39126937
- PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis.Front Immunol · 2022 · PMID 35355991
This page is information, not medical advice. Discuss any trial with your doctor.