Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

August 12, 2015 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Iranian Center for Neurological Researches, Imam Khomeini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Melatonin
3mg oral, daily, one hour before sleep
Active Comparator: Melatonin
Drug: Melatonin
3mg oral, daily, one hour before sleep

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MSFC score
Time Frame: 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)
one year (at the beginning and end of the year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Hossein Harirchian, M.D., Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8153-54-04-87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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