Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

NCT ID: NCT01279876

Last Updated: 2015-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-02-28

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Melatonin

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

3mg oral, daily, one hour before sleep

Placebo

Group Type: PLACEBO_COMPARATOR

Melatonin

Intervention Type: DRUG

3mg oral, daily, one hour before sleep

Interventions

Melatonin

3mg oral, daily, one hour before sleep

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Hossein Harirchian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Iranian Center for Neurological Researches, Imam Khomeini Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

8153-54-04-87

Identifier Type: -

Identifier Source: org_study_id