Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Phase 2

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Melatonin

• Registration Number: NCT01279876
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Melatonin	-
Melatonin	Melatonin	-

Primary Outcome Measures

Name	Time	Method
proportion of brain gray matter volume to intracranial volume	one year (at the beginning and end of the year)
EDSS	one year (every 3 months)	Expanded Disability Status Scale reported by a neurologist
Number of relapses	one year
PASAT-3 score	one year (at the beginning and end of the year)	Paced Auditory Serial Addition Test 3seconds score

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Iranian Center for Neurological Researches, Imam Khomeini Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of