Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Tehran University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT01279876

8153-54-04-87

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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