<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/NCT01709461</url>
  </required_header>
  <id_info>
    <org_study_id>RD 06 - 12</org_study_id>
    <nct_id>NCT01709461</nct_id>
  </id_info>
  <brief_title>Continuation Treatment Protocol for Patients Who Participated in the Adagio TVP 1012/501 Clinical Trial</brief_title>
  <official_title>Continue Providing Care for Patient Who Participated in the Adagio TVP 1012/501 Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects&#xD;
      who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Parkinson Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        subjects who took part in the TVP 1012/501 clinical trial and willing to contiue receiving&#xD;
        Rasgiline Mesylate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects who are willing to contiue this treatment.&#xD;
&#xD;
          -  subjects who took part in the TVP 1012/501 clinical trail.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who didn't take part in the TVP 1012/501 clinical trail.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ruth Djaldetti, Professor</last_name>
    <phone>972-9378218/9</phone>
    <email>ruthdjal@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yaniv roditi, Msc</last_name>
    <phone>972-39236843</phone>
    <email>yar@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rabin Medical Center Beilinson Campus</name>
      <address>
        <city>Petach Tiqva</city>
        <state>Hamerkaz</state>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Ruth Djaldetti, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_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/NCT01709461
org study id: RD 06 - 12
nct id: NCT01709461
lead sponsor: 
has dmc: No
the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects
      who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ruth Djaldetti, Professor
phone: 972-9378218/9
email: ruthdjal@clalit.org.il
last name: Yaniv roditi, Msc
phone: 972-39236843
email: yar@clalit.org.il
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Parkinson Disease