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Melatonin in Patients With Multiple Sclerosis (MS).

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
No Placebo-Only Group

Summary

This trial is testing melatonin supplements in patients with relapsing multiple sclerosis who are already on stable treatments. The goal is to see if melatonin can improve their sleep and overall quality of life. Melatonin has been studied for its potential benefits in improving sleep quality and overall well-being in various conditions, including multiple sclerosis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in urine melatonin levels
Secondary study objectives
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.

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
124 Previous Clinical Trials
823,757 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
189 Patients Enrolled for Multiple Sclerosis
Kyle Smoot, MDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
62 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
62 Patients Enrolled for Multiple Sclerosis
~4 spots leftby Dec 2025
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