Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01279876
First received: January 18, 2011
Last updated: August 12, 2015
Last verified: August 2015

January 18, 2011
August 12, 2015
October 2010
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01279876 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Melatonin in Relapsing-Remitting Multiple Sclerosis Patients
Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Drug: Melatonin
3mg oral, daily, one hour before sleep
  • Active Comparator: Melatonin
    Intervention: Drug: Melatonin
  • Placebo Comparator: Placebo
    Intervention: Drug: Melatonin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01279876
8153-54-04-87
Yes
Not Provided
Not Provided
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Mohammad Hossein Harirchian, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
August 2015

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