MedTrace Logo

Melatonin in Patients With Multiple Sclerosis (MS).

NCT03498131 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-30

Study results available
· View outcomes & findings →

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.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

3 mg Melatonin

3 mg melatonin once each day

DRUG

5 mg Melatonin

5 mg Melatonin once each day

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Kyle Smoot, MD · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2022-07-29
Completion
2023-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498131 on ClinicalTrials.gov