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OpenTrials
Completed

NCT Number: NCT01718678

Effect of Melatonin on Multiple Sclerosis Related Fatigue

The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.

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Key information

Conditions

Fatigue Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, 7007, Iran

About this study

Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria
  • a baseline of Expanded Disability Status Score (EDSS)of less than 5.0
  • aged between 18 and 55 years of either sex
  • treated with one type of interferon beta-1a (IFNB-1a);
  • signed an informed consent

Exclusion criteria

  • clinical relapsing of MS during past 30 days;
  • use of melatonin and warfarin within 30 days prior to participation;
  • concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ;
  • working more than one nighttime shift per month;
  • Pregnancy or lactation;
  • history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;
  • failure to adhere to the study protocol

Treatment and study plan

Melatonin

Drug

it is kind of drug

Placebo

Drug

It is Placebo

Primary outcomes

  1. Fatigue

    Time frame: at one month after treatment

    Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects.

Secondary outcomes

  1. Quality Of Life

    Time frame: at one month after treatment

    Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2012
Registry last updated
Oct 31, 2012

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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