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

October 28, 2012
October 31, 2012
October 31, 2012
May 2012
October 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
Effect of Melatonin on Multiple Sclerosis Related Fatigue
Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis
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.
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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Melatonin
    it is kind of drug
  • Drug: Placebo
    It is Placebo
  • Active Comparator: Melatonin
    Melatonin, Tablet, 3 mg, once, one month
    Intervention: Drug: Melatonin
  • Placebo Comparator: Placebo
    Placebo, tablet
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
Not Provided
Not Provided
Hamidreza Shemshaki, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Not Provided
Isfahan University of Medical Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP