Clinical Trial: Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome:

  • Number of relapses [ Time Frame: one year ]
  • EDSS [ Time Frame: one year (every 3 months) ]
    Expanded Disability Status Scale reported by a neurologist
  • PASAT-3 score [ Time Frame: one year (at the beginning and end of the year) ]
    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) ]


Original Primary Outcome: Same as current

Current Secondary Outcome: MSFC score [ Time Frame: one year (at the beginning and end of the year) ]

Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)


Original Secondary Outcome: Same as current

Information By: Tehran University of Medical Sciences

Dates:
Date Received: January 18, 2011
Date Started: October 2010
Date Completion:
Last Updated: August 12, 2015
Last Verified: August 2015