Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

This study is currently recruiting participants.

Verified July 2011 by Tehran University of Medical Sciences

Sponsor:

Information provided by:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01279876

First received: January 18, 2011

Last updated: July 25, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2011

Last Updated Date

July 25, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of relapses [ Time Frame: one year ] [ Designated as safety issue: Yes ]
EDSS [ Time Frame: one year (every 3 months) ] [ Designated as safety issue: Yes ]
Expanded Disability Status Scale reported by a neurologist
PASAT-3 score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]
Paced Auditory Serial Addition Test 3seconds score
proportion of brain gray matter volume to intracranial volume [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01279876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MSFC score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]

Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: Melatonin

3mg oral, daily, one hour before sleep

Study Arm (s)

Active Comparator: Melatonin
Intervention: Drug: Melatonin
Placebo Comparator: Placebo
Intervention: Drug: Melatonin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mohammad Hossein Harirchian, M.D.

88733731 ext +9821

harirchn@hotmail.com

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01279876

Other Study ID Numbers ^ICMJE

8153-54-04-87

Has Data Monitoring Committee

Yes

Responsible Party

Mohammad Hossein Harirchian, Tehran University of Medical Science

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mohammad Hossein Harirchian, M.D.

Tehran University of Medical Sciences

Information Provided By

Tehran University of Medical Sciences

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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