Effect of Melatonin on Multiple Sclerosis Related Fatigue

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01718678

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Drug: Melatonin Drug: Placebo	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Melatonin Melatonin, Tablet, 3 mg, once, one month	Drug: Melatonin it is kind of drug
Placebo Comparator: Placebo Placebo, tablet	Drug: Placebo It is Placebo

Arm

Intervention/Treatment

Active Comparator: Melatonin

Melatonin, Tablet, 3 mg, once, one month

Drug: Melatonin

it is kind of drug

Placebo Comparator: Placebo

Placebo, tablet

Drug: Placebo

It is Placebo

Outcome Measures

Primary Outcome Measures

Fatigue [at one month after treatment]
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.

Secondary Outcome Measures

Quality Of Life [at one month after treatment]
Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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