Effect of Melatonin on Multiple Sclerosis Related Fatigue

Fatigue Clinical Trial

Official title:

Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718678
• Other study ID #: ASD-12111
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2012
• Last updated: October 30, 2012
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis

Intervention

Drug:
• Melatonin
it is kind of drug
• Placebo
It is Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Isfahan university of medical sciences