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3 mg Melatonin for Multiple Sclerosis

Phase < 1
Waitlist Available
Led By Kyle Smoot, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights

Study Summary

This trial will explore the effect of melatonin supplementation in subjects with multiple sclerosis who are taking an oral disease modifying therapy. The results of this study could support the rationale for a larger trial to focus on clinical efficacy of melatonin therapy outcomes.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in urine melatonin levels
Secondary outcome measures
Modified Fatigue Impact Scale (MFIS)
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Patient Determined Disease Steps - Performance Scale (PDDS-PS)
+3 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3 mg Melatonin
2018
Completed Early Phase 1
~30
5 mg Melatonin
2018
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,505 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
180 Patients Enrolled for Multiple Sclerosis
Kyle Smoot, MDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
53 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
53 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Indiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Frontiers in ImmunologyJournal
PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis
Ghareghani, Majid, Zahra Farhadi, Serge Rivest, and Kazem Zibara. 2022. “PDK4 Inhibition Ameliorates Melatonin Therapy by Modulating Cerebral Metabolism and Remyelination in an EAE Demyelinating Mouse Model of Multiple Sclerosis”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2022.862316.
clinicaltrials.govStudy
Melatonin in Patients With Multiple Sclerosis (MS).
2018. "Melatonin in Patients With Multiple Sclerosis (MS).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03498131.
~4 spots leftby Apr 2025
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