Effect of Melatonin on Multiple Sclerosis Related Fatigue

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

Detailed Description
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Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Official Title
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Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

Conditions
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Fatigue

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria a baseline of Expanded Disability Status Score (EDSS)of less than 5.0 aged between 18 and 55 years of either sex treated with one type of interferon beta-1a (IFNB-1a); signed an informed consent Exclusion Criteria: clinical relapsing of MS during past 30 days; use of melatonin and warfarin within 30 days prior to participation; concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ; working more than one nighttime shift per month; Pregnancy or lactation; history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ; failure to adhere to the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br>Melatonin, Tablet, 3 mg, once, one month | Drug: Melatonin<br>* it is kind of drug<br>|
| Placebo Comparator: Placebo<br>Placebo, tablet | Drug: Placebo<br>* It is Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects. | at one month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Of Life | Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100. | at one month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Melatonin, Fatigue, Quality of life