Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279876
• Other study ID #: 8153-54-04-87
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2011
• Last updated: August 12, 2015
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: August 2015
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Melatonin
3mg oral, daily, one hour before sleep

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iranian Center for Neurological Researches, Imam Khomeini Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of relapses		one year	Yes
Primary	EDSS	Expanded Disability Status Scale reported by a neurologist	one year (every 3 months)	Yes
Primary	PASAT-3 score	Paced Auditory Serial Addition Test 3seconds score	one year (at the beginning and end of the year)	No
Primary	proportion of brain gray matter volume to intracranial volume		one year (at the beginning and end of the year)	No
Secondary	MSFC score	Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)	one year (at the beginning and end of the year)	No