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OpenTrials
Completed

NCT Number: NCT01279876

Melatonin in 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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Iranian Center for Neurological Researches, Imam Khomeini Hospital

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

3mg oral, daily, one hour before sleep

Primary outcomes

  1. Number of relapses

    Time frame: one year

  2. EDSS

    Time frame: one year (every 3 months)

    Expanded Disability Status Scale reported by a neurologist

  3. PASAT-3 score

    Time frame: one year (at the beginning and end of the year)

    Paced Auditory Serial Addition Test 3seconds score

  4. proportion of brain gray matter volume to intracranial volume

    Time frame: one year (at the beginning and end of the year)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2011
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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