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Effect of Melatonin on Multiple Sclerosis Related Fatigue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01718678
First received: October 28, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Fatigue
 Drug: Melatonin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

Resource links provided by NLM:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Fatigue [ Time Frame: at one month after treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at one month after treatment ] [ Designated as safety issue: Yes ]
    Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.


Enrollment: 44
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718678

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

Additional Information:
Isfahan university of medical sciences  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hamidreza Shemshaki, research assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01718678     History of Changes
Other Study ID Numbers: ASD-12111
Study First Received: October 28, 2012
Last Updated: October 30, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Multiple sclerosis
Melatonin
Fatigue
Quality of life

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

ClinicalTrials.gov processed this record on May 23, 2013