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
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3, 6, and 12 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
Melatonin
FDA approved
Melatonin
FDA approved

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Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
112 Previous Clinical Trials
58,640 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
213 Patients Enrolled for Multiple Sclerosis
Kyle Smoot, MDPrincipal Investigator
Providence Health & Services
2 Previous Clinical Trials
86 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
86 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

~5 spots leftby Oct 2024