Multiple Sclerosis, Relapsing-Remitting
Conditions
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 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.
Interventions
DRUGMelatonin
3mg oral, daily, one hour before sleep
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of relapses | one year | — |
| EDSS | one year (every 3 months) | Expanded Disability Status Scale reported by a neurologist |
| PASAT-3 score | 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 | one year (at the beginning and end of the year) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSFC score | 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) |
Countries
Iran
Outcome results
None listed