Effect of Melatonin on Multiple Sclerosis Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718678
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):
Hamidreza Shemshaki, 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.

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 Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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

Primary Outcome Measures :
  1. Fatigue [ Time Frame: 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 :
  1. Quality Of Life [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718678

Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of, 7007
Sponsors and Collaborators
Isfahan University of Medical Sciences

Additional Information:
Responsible Party: Hamidreza Shemshaki, research assistant, Isfahan University of Medical Sciences Identifier: NCT01718678     History of Changes
Other Study ID Numbers: ASD-12111
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Multiple sclerosis
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants