Effect of Melatonin on Multiple Sclerosis Related Fatigue

Phase 2

Completed

• Conditions: Fatigue
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT01718678
• Lead Sponsor: Isfahan University of Medical Sciences

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.

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 Timeline

• Study Start: 2012-05
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-28
• Study First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Study First Posted: 2012-10-31
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria
2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0
3. aged between 18 and 55 years of either sex
4. treated with one type of interferon beta-1a (IFNB-1a);
5. signed an informed consent

Exclusion Criteria

1. clinical relapsing of MS during past 30 days;
2. use of melatonin and warfarin within 30 days prior to participation;
3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ;
4. working more than one nighttime shift per month;
5. Pregnancy or lactation;
6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;
7. failure to adhere to the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, tablet
Melatonin	Melatonin	Melatonin, Tablet, 3 mg, once, one month

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of