<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/NCT03022201</url>
  </required_header>
  <id_info>
    <org_study_id>B-1210/173-006</org_study_id>
    <nct_id>NCT03022201</nct_id>
  </id_info>
  <brief_title>Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease</brief_title>
  <official_title>Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in&#xD;
      patients with Parkinson's disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are&#xD;
      frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been&#xD;
      some evidence that prokinetics might improve PD symptom fluctuations. From this background,&#xD;
      the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD&#xD;
      patients.&#xD;
&#xD;
      In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either&#xD;
      domperidone or DA-9701. The gastric function of each study participant will be evaluated&#xD;
      using the MRI technique before and after 4 weeks of the treatment. The study participants&#xD;
      will also be subjected to complete the gastrointestinal symptom diary before and during the&#xD;
      treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes&#xD;
      after dose administration before and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment</measure>
    <time_frame>0, 4 weeks</time_frame>
    <description>MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's symptoms of dyspepsia and constipation assessed patient diary</measure>
    <time_frame>-1 to 4 weeks</time_frame>
    <description>The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levodopa plasma concentration 30 minutes after the L-dopa administration</measure>
    <time_frame>0, 4 weeks</time_frame>
    <description>Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UPDRS Part III score</measure>
    <time_frame>0, 4 weeks</time_frame>
    <description>To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Parkinson's Disease,Idiopathic</condition>
  <arm_group>
    <arm_group_label>DA-9701</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Domperidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-9701</intervention_name>
    <description>Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.</description>
    <arm_group_label>DA-9701</arm_group_label>
    <other_name>Motilitone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Domperidone</intervention_name>
    <description>Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.</description>
    <arm_group_label>Domperidone</arm_group_label>
    <other_name>Motilium-M</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo domperidone</intervention_name>
    <arm_group_label>DA-9701</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo DA-9701</intervention_name>
    <arm_group_label>Domperidone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects diagnosed with spontaneous parkinsonism by the United Kingdom(UK) Parkinson's&#xD;
             Disease Society Brain Bank criteria&#xD;
&#xD;
          -  subjects who are able to explain symptoms they experience and to complete relevant&#xD;
             assessment and exams including questionaires&#xD;
&#xD;
          -  subjects who understand the purpose and protocols of the study and agree to&#xD;
             participate on the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who experience psychiatrical disorders such as cognitive or behavioral&#xD;
             disorders&#xD;
&#xD;
          -  subjects who are on prokinetics or who are unable to cease such medication&#xD;
&#xD;
          -  subjects who present neurological disorders which influence gastrointestinal mobility&#xD;
&#xD;
          -  subjects who present gastrointestinal conditions which influence gastrointestinal&#xD;
             mobility&#xD;
&#xD;
          -  subjects with a history of gastrectomy or colectomy&#xD;
&#xD;
          -  subjects who are unable to receive and complete the course of medication due to other&#xD;
             metabolic disorders&#xD;
&#xD;
          -  subjects diagnosed with parkinson plus syndrome&#xD;
&#xD;
          -  subjects who are unable to undergo MRI scan for safety reasons due to claustrophobia&#xD;
             or certain devices such as cardiac pacemakers or aneurysm clips&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheol Min Shin, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cheol Min Shin</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motilitone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03022201
org study id: B-1210/173-006
nct id: NCT03022201
lead sponsor: 
has dmc: No
This study will evaluate the therapeutic efficacy and safety of DA-9701 with domperidone in
      patients with Parkinson's disease
To prevent nausea and vomiting induced by anti-parkinsonian drugs, prokinetic drugs are
      frequently prescribed in patients with Parkinson's disease (PD). Additionally, there has been
      some evidence that prokinetics might improve PD symptom fluctuations. From this background,
      the investigators will evaluate the therapeutic efficacy and safety of DA-9701 in PD
      patients.

      In this study, 40 patients will be enrolled and randomly allocated 1:1 to receive either
      domperidone or DA-9701. The gastric function of each study participant will be evaluated
      using the MRI technique before and after 4 weeks of the treatment. The study participants
      will also be subjected to complete the gastrointestinal symptom diary before and during the
      treatment period. In addition, plasma levodopa concentrations will be determined 30 minutes
      after dose administration before and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of gastric motility evaluated using MRI from baseline at 4 weeks after the treatment
time frame: 0, 4 weeks
description: MRI is known to be accurate and useful in evaluating gastric motility. Gastric emptying rate (GER) evaluated using MRI will be compared before and after the treatment, and between the groups.
measure: Patient's symptoms of dyspepsia and constipation assessed patient diary
time frame: -1 to 4 weeks
description: The study participants will fill up the gastrointestinal symptom diary before and during the treatment period. In addition, the investigators will assess the Patient's Global Assessment (PGA) for dyspeptic symptoms at the end of the treatment period.
measure: Levodopa plasma concentration 30 minutes after the L-dopa administration
time frame: 0, 4 weeks
description: Plasma levodopa concentrations will be determined 30 minutes after L-dopa dose administration before and after treatment.
measure: UPDRS Part III score
time frame: 0, 4 weeks
description: To evaluate any deteriorations in Parkinson's disease, the investigators will assess Unified Parkinson's Disease Rating Scale (UPDRS) score before and after treatment in the 2 groups.
arm group label: DA-9701
arm group type: Experimental
description: In this arm, the study participants will receive DA-9701 30mg + placebo domperidone tablet tid ac for 4 weeks.
arm group label: Domperidone
arm group type: Active Comparator
description: (This study is a randomized, double-blinded, non-inferiority trial. Thus it is designed to have no placebo arm.) In this arm, the study participants will receive domperidone 10mg + placebo DA-9701 tablet tid ac +for 4 weeks.
intervention type: Drug
intervention name: DA-9701
description: Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
arm group label: DA-9701
other name: Motilitone
intervention type: Drug
intervention name: Domperidone
description: Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
arm group label: Domperidone
other name: Motilium-M
intervention type: Drug
intervention name: Placebo domperidone
arm group label: DA-9701
intervention type: Drug
intervention name: Placebo DA-9701
arm group label: Domperidone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Cheol Min Shin, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Domperidone
sharing ipd: No