Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

This study has been completed.
Information provided by (Responsible Party):
Tehran University of Medical Sciences Identifier:
First received: January 18, 2011
Last updated: August 12, 2015
Last verified: August 2015

The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Melatonin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Number of relapses [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • EDSS [ Time Frame: one year (every 3 months) ] [ Designated as safety issue: Yes ]
    Expanded Disability Status Scale reported by a neurologist

  • PASAT-3 score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]
    Paced Auditory Serial Addition Test 3seconds score

  • proportion of brain gray matter volume to intracranial volume [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MSFC score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]
    Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)

Enrollment: 25
Study Start Date: October 2010
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin Drug: Melatonin
3mg oral, daily, one hour before sleep
Placebo Comparator: Placebo Drug: Melatonin
3mg oral, daily, one hour before sleep

Detailed Description:

Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.


Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • definite diagnosis of relapsing-remitting multiple sclerosis
  • EDSS <=5
  • at least 6months consumption of interferon beta 1a

Exclusion Criteria:

  • illiteracy
  • evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes
  • relapse in the last 3 months
  • pregnancy or deciding to become pregnant during the following year
  • regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin
  • history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT01279876

Iran, Islamic Republic of
Iranian Center for Neurological Researches, Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Mohammad Hossein Harirchian, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences Identifier: NCT01279876     History of Changes
Other Study ID Numbers: 8153-54-04-87
Study First Received: January 18, 2011
Last Updated: August 12, 2015
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on October 08, 2015