Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

Detailed Description
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Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

Official Title
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Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: definite diagnosis of relapsing-remitting multiple sclerosis EDSS <=5 at least 6months consumption of interferon beta 1a Exclusion Criteria: illiteracy evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes relapse in the last 3 months pregnancy or deciding to become pregnant during the following year regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br> | Drug: Melatonin<br>* 3mg oral, daily, one hour before sleep<br>|
| Placebo Comparator: Placebo<br> | Drug: Melatonin<br>* 3mg oral, daily, one hour before sleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of relapses |  | one year | 
| EDSS | Expanded Disability Status Scale reported by a neurologist | one year (every 3 months) | 
| PASAT-3 score | Paced Auditory Serial Addition Test 3seconds score | one year (at the beginning and end of the year) | 
| proportion of brain gray matter volume to intracranial volume |  | one year (at the beginning and end of the year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSFC score | Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score) | one year (at the beginning and end of the year) |