<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/NCT03258294</url>
  </required_header>
  <id_info>
    <org_study_id>2015-09-098-010</org_study_id>
    <nct_id>NCT03258294</nct_id>
  </id_info>
  <brief_title>Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease</brief_title>
  <official_title>Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KIMJisun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kuhnil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study is a double-blind, randomized, placebo-controlled trial to investigate&#xD;
      the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,&#xD;
      symptoms which have a significant impact on the quality of life of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After selecting patients who satisfied the inclusion criteria and were not disqualified by&#xD;
      the exclusion criteria, through a double-blind procedure the patients are directed to orally&#xD;
      take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4&#xD;
      weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed&#xD;
      at the first baseline and immediately after administering the drug for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 13, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation in PSQI(Pittsburgh Sleep Quality Index)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
    <description>Variation in PSQI before and immediately after the administration of the drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in PDSS(The Parkinson's Disease Sleep Scale)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in ESS(The Epworth Sleepiness Scale)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in UPDRS(Unified Parkinson Disease Rating Scale)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in H &amp; Y Scale(Hoehn and Yahr Scale)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in NMSS(Non-Motor Symptom assessment Scale)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Variations in CGI(Clinical Global Impression)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Variations in PGI(Patient Global Impression)</measure>
    <time_frame>Baseline and immediately after administering the drug for 4 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>4 weeks of drug treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of subjects with serious adverse events</measure>
    <time_frame>4 weeks of drug treatment</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Melatonin(Circadin®)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin(Circadin®)</intervention_name>
    <arm_group_label>Melatonin(Circadin®)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who meet the clinical criteria for idiopathic Parkinson's disease (United&#xD;
             Kingdom Parkinson's Disease Brain Bank Criteria)&#xD;
&#xD;
          2. Patients who complain of sleep disturbances such as insomnia, REM sleep behavior&#xD;
             disorder, excessive daytime sleepiness (EDS), etc.&#xD;
&#xD;
          3. Patients who have received drug treatment for at least 6 months since their diagnosis&#xD;
&#xD;
          4. Male or female patient aged 55 or older&#xD;
&#xD;
          5. Patients who have given voluntary consent after understanding the content of the&#xD;
             clinical trial (in the case of elderly patients aged 70 or older, consent must be&#xD;
             received from both the subject and the his or her legal representative)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness&#xD;
&#xD;
          2. Patients with a serious medical disease&#xD;
&#xD;
               -  Patients who concomitantly suffer from severe renal impairment, convulsions,&#xD;
                  stomach ulcers, moderate or more severe liver disease&#xD;
&#xD;
               -  Patients with un-controlled high blood pressure or diabetes&#xD;
&#xD;
          3. Patients who have taken another investigational products within 4 weeks prior to being&#xD;
             enrolled in this clinical trial, or patients who are pregnant or breastfeeding&#xD;
&#xD;
          4. Patients who have a history of hypersensitivity to the investigational products or a&#xD;
             drug similar in component or who have had heavy metal poisoning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jisun Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center, Department of Neurology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eungseok Oh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital, Department of Neurology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wooyoung Jang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangneung Asan Hospital, Department of Neurology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jinse Park</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University Haeundae Paik Hospital, Department of Neurology</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 20, 2017</last_update_submitted>
  <last_update_submitted_qc>August 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>KIMJisun</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>melatonin</keyword>
  <keyword>sleep disturbances</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 19, 2018</submitted>
    <returned>February 8, 2019</returned>
  </pending_results>
  <!-- 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/NCT03258294
org study id: 2015-09-098-010
nct id: NCT03258294
lead sponsor: 
collaborator: 
has dmc: No
This clinical study is a double-blind, randomized, placebo-controlled trial to investigate
      the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients,
      symptoms which have a significant impact on the quality of life of these patients.
After selecting patients who satisfied the inclusion criteria and were not disqualified by
      the exclusion criteria, through a double-blind procedure the patients are directed to orally
      take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4
      weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed
      at the first baseline and immediately after administering the drug for 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Variation in PSQI(Pittsburgh Sleep Quality Index)
time frame: Baseline and immediately after administering the drug for 4 weeks
description: Variation in PSQI before and immediately after the administration of the drug
measure: Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PDSS(The Parkinson's Disease Sleep Scale)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in ESS(The Epworth Sleepiness Scale)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in UPDRS(Unified Parkinson Disease Rating Scale)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in H & Y Scale(Hoehn and Yahr Scale)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in NMSS(Non-Motor Symptom assessment Scale)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in CGI(Clinical Global Impression)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PGI(Patient Global Impression)
time frame: Baseline and immediately after administering the drug for 4 weeks
measure: Number of subjects with adverse events
time frame: 4 weeks of drug treatment
measure: Number of subjects with serious adverse events
time frame: 4 weeks of drug treatment
arm group label: Melatonin(Circadin®)
arm group type: Experimental
description: Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
intervention type: Drug
intervention name: Melatonin(Circadin®)
arm group label: Melatonin(Circadin®)
intervention type: Drug
intervention name: Placebo Oral Tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Jisun Kim
role: Principal Investigator
affiliation: Samsung Medical Center, Department of Neurology
last name: Eungseok Oh
role: Principal Investigator
affiliation: Chungnam National University Hospital, Department of Neurology
last name: Wooyoung Jang
role: Principal Investigator
affiliation: Gangneung Asan Hospital, Department of Neurology
last name: Jinse Park
role: Principal Investigator
affiliation: Inje University Haeundae Paik Hospital, Department of Neurology
responsible party type: Sponsor-Investigator
investigator affiliation: Samsung Medical Center
investigator full name: KIMJisun
investigator title: Instructor
mesh term: Parkinson Disease
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Melatonin
sharing ipd: No
submitted: September 19, 2018
returned: February 8, 2019