<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718678</url>
  </required_header>
  <id_info>
    <org_study_id>ASD-12111</org_study_id>
    <nct_id>NCT01718678</nct_id>
  </id_info>
  <brief_title>Effect of Melatonin on Multiple Sclerosis Related Fatigue</brief_title>
  <official_title>Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment&#xD;
      of fatigue and Quality of Life of MS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the&#xD;
      world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System&#xD;
      (CNS) which affects individuals in the productive ages and causes a large burden for years to&#xD;
      come. Fatigue is a common complaint and one of the least understood symptoms of MS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>at one month after treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life</measure>
    <time_frame>at one month after treatment</time_frame>
    <description>Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Melatonin, Tablet, 3 mg, once, one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>it is kind of drug</description>
    <arm_group_label>Melatonin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>It is Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria&#xD;
&#xD;
          2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0&#xD;
&#xD;
          3. aged between 18 and 55 years of either sex&#xD;
&#xD;
          4. treated with one type of interferon beta-1a (IFNB-1a);&#xD;
&#xD;
          5. signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. clinical relapsing of MS during past 30 days;&#xD;
&#xD;
          2. use of melatonin and warfarin within 30 days prior to participation;&#xD;
&#xD;
          3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS,&#xD;
             aspirin ;&#xD;
&#xD;
          4. working more than one nighttime shift per month;&#xD;
&#xD;
          5. Pregnancy or lactation;&#xD;
&#xD;
          6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ;&#xD;
&#xD;
          7. failure to adhere to the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Al-zahra university hospital</name>
      <address>
        <city>Isfahan</city>
        <zip>7007</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://www.mui.ac.ir</url>
    <description>Isfahan university of medical sciences</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hamidreza Shemshaki</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Melatonin</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718678
org study id: ASD-12111
nct id: NCT01718678
lead sponsor: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fatigue
time frame: at one month after treatment
description: 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.
measure: Quality Of Life
time frame: at one month after treatment
description: Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.
arm group label: Melatonin
arm group type: Active Comparator
description: Melatonin, Tablet, 3 mg, once, one month
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, tablet
intervention type: Drug
intervention name: Melatonin
description: it is kind of drug
arm group label: Melatonin
intervention type: Drug
intervention name: Placebo
description: It is Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
url: http://www.mui.ac.ir
description: Isfahan university of medical sciences
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Hamidreza Shemshaki
investigator title: research assistant
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue
mesh term: Melatonin