<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/NCT02231918</url>
  </required_header>
  <id_info>
    <org_study_id>248.600</org_study_id>
    <nct_id>NCT02231918</nct_id>
  </id_info>
  <brief_title>Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)</brief_title>
  <official_title>An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a&#xD;
      single dose orally (p.o.) in pediatric patients with the diagnosis of RLS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2006</start_date>
  <primary_completion_date type="Actual">July 2007</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmin,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cpre,N</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cavg</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Average concentration of the analyte in plasma at steady state (Cavg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Time from dosing to maximum concentration at steady state (Tmax,ss).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmin,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Time from dosing to minimum concentration at steady state (Tmin,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,ss</measure>
    <time_frame>0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.</time_frame>
    <description>Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>λz,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Terminal rate constant in plasma at steady state (λz,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRTpo,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Mean residence time of the analyte in the body at steady state (MRTpo,ss).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz/F,ss</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ae 0-12,ss</measure>
    <time_frame>12 hours after last study drug administration on day 1</time_frame>
    <description>Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fe 0-12,ss</measure>
    <time_frame>12 hours after last study drug administration on day 1.</time_frame>
    <description>Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CLR,ss</measure>
    <time_frame>12h after last study drug administration on day 1</time_frame>
    <description>Renal clearance of the analyte at steady state (CLR(0-12),ss ).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTF</measure>
    <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
    <description>Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Drug Related Adverse Events</measure>
    <time_frame>From first drug administration until 24 hours after last study drug administration, upto 48 days</time_frame>
    <description>Number of patients with adverse events due to study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs (Systolic and Diastolic Blood Pressure)</measure>
    <time_frame>-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.</time_frame>
    <description>Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs (Pulse Rate)</measure>
    <time_frame>-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h</time_frame>
    <description>Vital signs (Pulse rate (both supine and after standing for 1 minute)).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Restless Legs Syndrome</condition>
  <arm_group>
    <arm_group_label>MIRAPEX® - low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MIRAPEX® - medium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MIRAPEX® - high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MIRAPEX® - low</intervention_name>
    <arm_group_label>MIRAPEX® - low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MIRAPEX® - medium</intervention_name>
    <arm_group_label>MIRAPEX® - medium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MIRAPEX® - high</intervention_name>
    <arm_group_label>MIRAPEX® - high</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12&#xD;
             to 16 years, with the same number of patients if possible)&#xD;
&#xD;
          2. Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS&#xD;
             criteria of the International Restless Legs Syndrome Study Group (IRLSSG)&#xD;
&#xD;
             All 4 of the following criteria must be present:&#xD;
&#xD;
               -  An urge to move the legs, usually accompanied or caused by uncomfortable and&#xD;
                  unpleasant sensations in the legs. (Sometimes the urge to move is present without&#xD;
                  the uncomfortable sensations and sometimes the arms or other body parts are&#xD;
                  involved in addition to the legs.)&#xD;
&#xD;
               -  The urge to move or unpleasant sensations begin or worsen during periods of rest&#xD;
                  or inactivity such as lying or sitting&#xD;
&#xD;
               -  The urge to move or unpleasant sensations are partially or totally relieved by&#xD;
                  movement, such as walking or stretching, at least as long as the activity&#xD;
                  continues&#xD;
&#xD;
               -  The urge to move or unpleasant sensations are worse in the evening or night than&#xD;
                  during the day or only occur in the evening or night. (When symptoms are very&#xD;
                  severe, the worsening at night may not be noticeable but must have been&#xD;
                  previously present.)&#xD;
&#xD;
          3. Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No.&#xD;
             2 above) and either:&#xD;
&#xD;
               1. The child must be able to describe the leg discomfort in their own words or&#xD;
&#xD;
               2. The child must have 2 or 3 of the following:&#xD;
&#xD;
                    -  Sleep disturbance&#xD;
&#xD;
                    -  Periodic Limb Movements During Sleep (PLMS) index &gt;5 per hour of sleep, or&#xD;
&#xD;
                    -  A biological parent or sibling with definite RLS&#xD;
&#xD;
          4. Written informed consent consistent with International Conference on Harmonisation&#xD;
             (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements&#xD;
             for children obtained prior to any study procedures being performed&#xD;
&#xD;
          5. Ability and willingness to comply with the study treatment regimen and to attend study&#xD;
             assessments&#xD;
&#xD;
          6. Must be on PPX treatment at the same evening maintenance dose for a minimum of 7 days&#xD;
             prior to entry into this study as determined by the investigator&#xD;
&#xD;
          7. A patient who is taking PPX but not as an evening maintenance dose may return for a&#xD;
             repeat screening if the patient can be successfully switched and re-stabilized to an&#xD;
             evening PPX maintenance dose&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Any women of childbearing potential having a positive serum pregnancy test at&#xD;
             screening&#xD;
&#xD;
          2. Any women of childbearing potential not using a medically accepted method of&#xD;
             contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and&#xD;
             estrogen patch, double barrier method [spermicide + diaphragm], or abstinence at the&#xD;
             discretion of the investigator)&#xD;
&#xD;
          3. Patients who have a clinically significant renal disease or serum creatinine level&#xD;
             greater than 1.0 mg/dL at screening&#xD;
&#xD;
          4. Any of the following lab results at screening:&#xD;
&#xD;
               -  Hemoglobin (Hgb) below the lower limit of normal (LLN), which is determined to be&#xD;
                  clinically significant&#xD;
&#xD;
               -  Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4)&#xD;
                  clinically significantly (at the investigator's discretion) out of the normal&#xD;
                  range at screening (if not caused by substitution therapy according to the&#xD;
                  investigator's opinion)&#xD;
&#xD;
               -  Patients with any clinically significant abnormalities in laboratory parameters&#xD;
                  at screening at the investigator's discretion&#xD;
&#xD;
          5. Other clinically significant metabolic-endocrine, hematological, gastrointestinal&#xD;
             disease, pulmonary disease (such as severe asthma) which in the opinion of the&#xD;
             investigator would preclude the patient from participating in this study&#xD;
&#xD;
          6. History or clinical signs of any neurological disease with potential to secondarily&#xD;
             cause RLS symptoms&#xD;
&#xD;
          7. Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior&#xD;
             disorder, narcolepsy, or sleep apnea syndrome&#xD;
&#xD;
          8. History of schizophrenia or any psychotic disorder, history of mental disorders, or&#xD;
             any present Axis I psychiatric disorder according to the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders, 4th edition (DSM-IV) requiring any medical therapy&#xD;
&#xD;
          9. History of/or clinical signs of epilepsy or seizures other than fever-related seizures&#xD;
             in early childhood&#xD;
&#xD;
         10. History of/or clinical signs of any malignant neoplasm including suspicious&#xD;
             undiagnosed skin lesions (which may be melanoma), melanoma, or a history of melanoma&#xD;
&#xD;
         11. Any other conditions that, in the opinion of the investigator, would interfere with&#xD;
             the evaluation of the results or constitute a health hazard for the patient&#xD;
&#xD;
         12. Allergic response to PPX or the inactive ingredients in its tablet formulation&#xD;
&#xD;
         13. Had previous treatment with dopamine agonists other than PPX within 14 days prior to&#xD;
             the baseline visit&#xD;
&#xD;
         14. Had any other medical treatment for RLS besides the study medication within 14 days&#xD;
             prior to the baseline visit&#xD;
&#xD;
         15. Had withdrawal symptoms of any medication at screening or at the baseline visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <results_first_submitted>July 17, 2015</results_first_submitted>
  <results_first_submitted_qc>September 2, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 6, 2015</results_first_posted>
  <last_update_submitted>September 2, 2015</last_update_submitted>
  <last_update_submitted_qc>September 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2015</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>Psychomotor Agitation</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pramipexole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Open label, single dose pharmacokinetic study in pediatric patients with a diagnosis of idiopathic Restless Legs Syndrome(RLS). For the dose MIRAPEX(0.5 mg),Only 2 subjects (12 to&lt;18 years) were recruited and it was not likely that patients for this dose will be fully recruited so the recruitment was stopped and terminated for this dose only.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PPX (MIRAPEX®, 0.125 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="P2">
          <title>PPX (MIRAPEX®, 0.25 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="P3">
          <title>PPX (MIRAPEX®, 0.5 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>PPX (MIRAPEX®, 0.125 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="B2">
          <title>PPX (MIRAPEX®, 0.25 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="B3">
          <title>PPX (MIRAPEX®, 0.5 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="4.3"/>
                    <measurement group_id="B2" value="11.4" spread="3.4"/>
                    <measurement group_id="B3" value="15.0" spread="0.0"/>
                    <measurement group_id="B4" value="11.4" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax,ss</title>
        <description>Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax,ss</title>
          <description>Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 9, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.633" spread="26.2"/>
                    <measurement group_id="O2" value="1.13" spread="35.3"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years(N=4, 6, 2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.396" spread="30.0"/>
                    <measurement group_id="O2" value="0.677" spread="40.3"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the geometric mean (gMean) and geometric coefficient of variation (gCV) is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmin,ss</title>
        <description>Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmin,ss</title>
          <description>Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 9, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0872" spread="35.5"/>
                    <measurement group_id="O2" value="0.136" spread="99.5"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years(N=4, 6, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0972" spread="37.5"/>
                    <measurement group_id="O2" value="0.122" spread="53.8"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cpre,N</title>
        <description>Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Cpre,N</title>
          <description>Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=4, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.074" spread="17.3"/>
                    <measurement group_id="O2" value="0.147" spread="75.3"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=1, 5, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                    <measurement group_id="O2" value="0.112" spread="60.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cavg</title>
        <description>Average concentration of the analyte in plasma at steady state (Cavg).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Cavg</title>
          <description>Average concentration of the analyte in plasma at steady state (Cavg).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.213" spread="27.4"/>
                    <measurement group_id="O2" value="0.458" spread="42.8"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.137" spread="21.3"/>
                    <measurement group_id="O2" value="0.309" spread="35.2"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax,ss</title>
        <description>Time from dosing to maximum concentration at steady state (Tmax,ss).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax,ss</title>
          <description>Time from dosing to maximum concentration at steady state (Tmax,ss).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 9, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.00" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.96" lower_limit="0.50" upper_limit="5.00"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmin,ss</title>
        <description>Time from dosing to minimum concentration at steady state (Tmin,ss ).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmin,ss</title>
          <description>Time from dosing to minimum concentration at steady state (Tmin,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 9, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="0.50" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="0.25" upper_limit="24.0"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" lower_limit="0.50" upper_limit="12.0"/>
                    <measurement group_id="O2" value="23.9" lower_limit="0.50" upper_limit="24.0"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the median and range are not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUCτ,ss</title>
        <description>Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).</description>
        <time_frame>0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCτ,ss</title>
          <description>Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.12" spread="27.4"/>
                    <measurement group_id="O2" value="11.0" spread="42.8"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.28" spread="21.3"/>
                    <measurement group_id="O2" value="7.42" spread="35.2"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>λz,ss</title>
        <description>Terminal rate constant in plasma at steady state (λz,ss ).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>λz,ss</title>
          <description>Terminal rate constant in plasma at steady state (λz,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>1/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.132" spread="22.6"/>
                    <measurement group_id="O2" value="0.107" spread="20.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.113" spread="1.88"/>
                    <measurement group_id="O2" value="0.0938" spread="25.4"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>t1/2,ss</title>
        <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>t1/2,ss</title>
          <description>Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.26" spread="22.6"/>
                    <measurement group_id="O2" value="6.50" spread="20.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.13" spread="1.88"/>
                    <measurement group_id="O2" value="7.39" spread="25.4"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRTpo,ss</title>
        <description>Mean residence time of the analyte in the body at steady state (MRTpo,ss).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>MRTpo,ss</title>
          <description>Mean residence time of the analyte in the body at steady state (MRTpo,ss).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.19" spread="13.1"/>
                    <measurement group_id="O2" value="10.1" spread="19.5"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.47" spread="5.30"/>
                    <measurement group_id="O2" value="11.6" spread="23.3"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F,ss</title>
        <description>Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F,ss</title>
          <description>Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>mL/min</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="284" spread="27.4"/>
                    <measurement group_id="O2" value="265" spread="42.8"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="444" spread="21.3"/>
                    <measurement group_id="O2" value="393" spread="35.2"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vz/F,ss</title>
        <description>Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Vz/F,ss</title>
          <description>Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>L</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129" spread="12.3"/>
                    <measurement group_id="O2" value="149" spread="29.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6,1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="236" spread="19.4"/>
                    <measurement group_id="O2" value="251" spread="37.3"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ae 0-12,ss</title>
        <description>Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).</description>
        <time_frame>12 hours after last study drug administration on day 1</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Ae 0-12,ss</title>
          <description>Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>ng</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=4, 6, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50600" spread="14.6"/>
                    <measurement group_id="O2" value="123000" spread="50.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=3, 6, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55200" spread="41.5"/>
                    <measurement group_id="O2" value="82300" spread="52.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data was available of any patients for this category, so there was no data to analyse.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>fe 0-12,ss</title>
        <description>Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).</description>
        <time_frame>12 hours after last study drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>fe 0-12,ss</title>
          <description>Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>% of PPX excreted</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=4, 2, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0" spread="14.6"/>
                    <measurement group_id="O2" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">No patients were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=2, 5, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                    <measurement group_id="O2" value="42.0" spread="48.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data was available of any patients for this category, so there was no data to analyse.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CLR,ss</title>
        <description>Renal clearance of the analyte at steady state (CLR(0-12),ss ).</description>
        <time_frame>12h after last study drug administration on day 1</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>CLR,ss</title>
          <description>Renal clearance of the analyte at steady state (CLR(0-12),ss ).</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>mL/min</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=4, 2, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201" spread="34.1"/>
                    <measurement group_id="O2" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">No subjects were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=2, 5, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                    <measurement group_id="O2" value="253" spread="34.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data was available of any patients for this category, so there was no data to analyse.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PTF</title>
        <description>Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.</description>
        <time_frame>0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.</time_frame>
        <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>PTF</title>
          <description>Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.</description>
          <population>Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.</population>
          <units>% of PTF</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 to &lt;12 years (N=5, 8, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="250" spread="10.1"/>
                    <measurement group_id="O2" value="209" spread="31.8"/>
                    <measurement group_id="O3" value="NA" spread="NA">No subjects were recruited for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years (N=4, 6, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216" spread="24.0"/>
                    <measurement group_id="O2" value="168" spread="34.2"/>
                    <measurement group_id="O3" value="NA" spread="NA">The reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Drug Related Adverse Events</title>
        <description>Number of patients with adverse events due to study drug.</description>
        <time_frame>From first drug administration until 24 hours after last study drug administration, upto 48 days</time_frame>
        <population>Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Drug Related Adverse Events</title>
          <description>Number of patients with adverse events due to study drug.</description>
          <population>Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vital Signs (Systolic and Diastolic Blood Pressure)</title>
        <description>Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).</description>
        <time_frame>-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.</time_frame>
        <population>Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Vital Signs (Systolic and Diastolic Blood Pressure)</title>
          <description>Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).</description>
          <population>Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,2): -0:15h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.33" spread="6.76"/>
                    <measurement group_id="O2" value="109.20" spread="10.80"/>
                    <measurement group_id="O3" value="117.00" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,2): 0:30h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.89" spread="13.90"/>
                    <measurement group_id="O2" value="110.33" spread="14.07"/>
                    <measurement group_id="O3" value="116.00" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,2): 1:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.00" spread="11.07"/>
                    <measurement group_id="O2" value="108.07" spread="12.92"/>
                    <measurement group_id="O3" value="105.50" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,2): 2:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.00" spread="7.43"/>
                    <measurement group_id="O2" value="111.93" spread="13.79"/>
                    <measurement group_id="O3" value="113.00" spread="9.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,1): 3:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.89" spread="10.40"/>
                    <measurement group_id="O2" value="110.53" spread="11.34"/>
                    <measurement group_id="O3" value="113.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,15,1): 5:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.11" spread="12.71"/>
                    <measurement group_id="O2" value="108.80" spread="14.89"/>
                    <measurement group_id="O3" value="104.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,14,1): 7:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.44" spread="12.27"/>
                    <measurement group_id="O2" value="109.86" spread="14.11"/>
                    <measurement group_id="O3" value="108.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,14,1): 12:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.56" spread="16.38"/>
                    <measurement group_id="O2" value="106.93" spread="16.28"/>
                    <measurement group_id="O3" value="109.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-supine(N= 9,14,1): 24:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.22" spread="11.38"/>
                    <measurement group_id="O2" value="112.21" spread="13.76"/>
                    <measurement group_id="O3" value="120.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,2): -0:15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.67" spread="7.35"/>
                    <measurement group_id="O2" value="65.73" spread="10.19"/>
                    <measurement group_id="O3" value="76.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,2): 0:30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.67" spread="8.93"/>
                    <measurement group_id="O2" value="65.80" spread="12.62"/>
                    <measurement group_id="O3" value="73.00" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,2): 1:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.33" spread="6.52"/>
                    <measurement group_id="O2" value="65.73" spread="7.80"/>
                    <measurement group_id="O3" value="64.00" spread="12.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,2): 2:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.00" spread="8.23"/>
                    <measurement group_id="O2" value="65.80" spread="8.76"/>
                    <measurement group_id="O3" value="75.00" spread="8.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,1): 3:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.78" spread="9.36"/>
                    <measurement group_id="O2" value="65.40" spread="9.96"/>
                    <measurement group_id="O3" value="75.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,15,1): 5:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.22" spread="9.83"/>
                    <measurement group_id="O2" value="63.87" spread="9.78"/>
                    <measurement group_id="O3" value="70.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,14,1): 7:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.56" spread="13.47"/>
                    <measurement group_id="O2" value="62.43" spread="8.08"/>
                    <measurement group_id="O3" value="67.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,14,1): 12:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.00" spread="12.03"/>
                    <measurement group_id="O2" value="61.00" spread="9.12"/>
                    <measurement group_id="O3" value="66.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-supine(N= 9,14,1): 24:00</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.56" spread="6.00"/>
                    <measurement group_id="O2" value="65.71" spread="7.61"/>
                    <measurement group_id="O3" value="78.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,15,2):-0:15h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.89" spread="8.57"/>
                    <measurement group_id="O2" value="113.93" spread="9.97"/>
                    <measurement group_id="O3" value="122.00" spread="9.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,15,2): 0:30h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.56" spread="13.62"/>
                    <measurement group_id="O2" value="113.67" spread="13.69"/>
                    <measurement group_id="O3" value="115.50" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,15,2): 1:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.11" spread="13.81"/>
                    <measurement group_id="O2" value="110.07" spread="14.26"/>
                    <measurement group_id="O3" value="125.50" spread="23.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,15,2): 2:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.33" spread="8.76"/>
                    <measurement group_id="O2" value="112.27" spread="12.26"/>
                    <measurement group_id="O3" value="115.00" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,15,1): 3:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.11" spread="16.50"/>
                    <measurement group_id="O2" value="113.07" spread="16.15"/>
                    <measurement group_id="O3" value="108.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,14,1): 5:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.22" spread="11.88"/>
                    <measurement group_id="O2" value="111.93" spread="14.91"/>
                    <measurement group_id="O3" value="115.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N= 9,13,1): 7:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.11" spread="11.76"/>
                    <measurement group_id="O2" value="103.85" spread="17.56"/>
                    <measurement group_id="O3" value="65.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N=9,14,1): 12:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.22" spread="9.59"/>
                    <measurement group_id="O2" value="107.14" spread="15.83"/>
                    <measurement group_id="O3" value="100.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure-standing(N=9,14,1): 24:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.89" spread="11.25"/>
                    <measurement group_id="O2" value="115.50" spread="14.43"/>
                    <measurement group_id="O3" value="102.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolicblood pressure-standing(N=9,15,2): -0:15h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.11" spread="11.87"/>
                    <measurement group_id="O2" value="71.20" spread="8.09"/>
                    <measurement group_id="O3" value="86.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,15,2): 0:30h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.11" spread="7.44"/>
                    <measurement group_id="O2" value="69.20" spread="12.11"/>
                    <measurement group_id="O3" value="80.00" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,15,2): 1:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.22" spread="6.36"/>
                    <measurement group_id="O2" value="72.00" spread="9.54"/>
                    <measurement group_id="O3" value="91.00" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,15,2): 2:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.11" spread="8.82"/>
                    <measurement group_id="O2" value="73.13" spread="9.36"/>
                    <measurement group_id="O3" value="86.50" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,15,1): 3:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.67" spread="5.94"/>
                    <measurement group_id="O2" value="71.47" spread="8.98"/>
                    <measurement group_id="O3" value="79.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,14,1): 5:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.00" spread="10.82"/>
                    <measurement group_id="O2" value="70.57" spread="9.20"/>
                    <measurement group_id="O3" value="98.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,13,1):7:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.00" spread="13.01"/>
                    <measurement group_id="O2" value="66.69" spread="10.90"/>
                    <measurement group_id="O3" value="48.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure-standing(N=9,14,1):12:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.33" spread="11.19"/>
                    <measurement group_id="O2" value="70.07" spread="10.51"/>
                    <measurement group_id="O3" value="62.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolicblood pressure-standing(N=9,14,1):24:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.11" spread="8.13"/>
                    <measurement group_id="O2" value="73.57" spread="9.62"/>
                    <measurement group_id="O3" value="84.00" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vital Signs (Pulse Rate)</title>
        <description>Vital signs (Pulse rate (both supine and after standing for 1 minute)).</description>
        <time_frame>-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>PPX (MIRAPEX®, 0.125 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O2">
            <title>PPX (MIRAPEX®, 0.25 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
          <group group_id="O3">
            <title>PPX (MIRAPEX®, 0.5 mg)</title>
            <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
          </group>
        </group_list>
        <measure>
          <title>Vital Signs (Pulse Rate)</title>
          <description>Vital signs (Pulse rate (both supine and after standing for 1 minute)).</description>
          <population>Safety analysis set</population>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pulse rate-supine(N=9,15,2): -0:15h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" spread="18.6"/>
                    <measurement group_id="O2" value="73.3" spread="6.8"/>
                    <measurement group_id="O3" value="75.5" spread="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,15,2): 0:30h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.7" spread="17.5"/>
                    <measurement group_id="O2" value="78.0" spread="11.7"/>
                    <measurement group_id="O3" value="92.0" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,15,2): 1:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7" spread="22.2"/>
                    <measurement group_id="O2" value="75.2" spread="6.8"/>
                    <measurement group_id="O3" value="87.0" spread="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,15,2): 2:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.4" spread="19.6"/>
                    <measurement group_id="O2" value="77.9" spread="8.0"/>
                    <measurement group_id="O3" value="94.5" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,15,1): 3:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3" spread="19.1"/>
                    <measurement group_id="O2" value="79.9" spread="13.6"/>
                    <measurement group_id="O3" value="72.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,15,1): 5:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7" spread="16.0"/>
                    <measurement group_id="O2" value="75.9" spread="6.9"/>
                    <measurement group_id="O3" value="77.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,14,1): 7:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.1" spread="18.1"/>
                    <measurement group_id="O2" value="72.0" spread="9.0"/>
                    <measurement group_id="O3" value="78.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,14,1): 12:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" spread="15.2"/>
                    <measurement group_id="O2" value="68.6" spread="6.2"/>
                    <measurement group_id="O3" value="69.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate-supine(N=9,14,1): 24:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.9" spread="13.6"/>
                    <measurement group_id="O2" value="77.6" spread="8.5"/>
                    <measurement group_id="O3" value="77.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing(N=9,15,2):-0:15h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="18.3"/>
                    <measurement group_id="O2" value="79.4" spread="8.7"/>
                    <measurement group_id="O3" value="99.0" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing(N=9,15,2): 0:30h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.7" spread="15.5"/>
                    <measurement group_id="O2" value="81.5" spread="12.2"/>
                    <measurement group_id="O3" value="103" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing(N=9,15,2): 1:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.8" spread="20.3"/>
                    <measurement group_id="O2" value="85.4" spread="10.9"/>
                    <measurement group_id="O3" value="123" spread="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,15,2): 2:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.8" spread="17.0"/>
                    <measurement group_id="O2" value="89.3" spread="11.2"/>
                    <measurement group_id="O3" value="121" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,15,1): 3:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" spread="18.2"/>
                    <measurement group_id="O2" value="92.7" spread="12.9"/>
                    <measurement group_id="O3" value="109" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,14,1): 5:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" spread="27.0"/>
                    <measurement group_id="O2" value="87.1" spread="11.4"/>
                    <measurement group_id="O3" value="76.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,13,1): 7:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="17.0"/>
                    <measurement group_id="O2" value="82.1" spread="14.4"/>
                    <measurement group_id="O3" value="72.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,14,1): 12:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" spread="12.4"/>
                    <measurement group_id="O2" value="81.2" spread="12.3"/>
                    <measurement group_id="O3" value="86.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate- standing (N=9,14,1): 24:00h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="18.8"/>
                    <measurement group_id="O2" value="85.8" spread="6.7"/>
                    <measurement group_id="O3" value="86.0" spread="NA">The data of only one patient is available and thus Standard Deviation is not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 24 hours after last study drug administration, upto 48 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MIRAPEX® (0.125 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="E2">
          <title>MIRAPEX® (0.25 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
        <group group_id="E3">
          <title>MIRAPEX® (0.5 mg)</title>
          <description>Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA 10.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infusion site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vessel puncture site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim Pharmaceuticals</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02231918
org study id: 248.600
nct id: NCT02231918
lead sponsor: 
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a
      single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
measure: Cmin,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
measure: Cpre,N
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).
measure: Cavg
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Average concentration of the analyte in plasma at steady state (Cavg).
measure: Tmax,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Time from dosing to maximum concentration at steady state (Tmax,ss).
measure: Tmin,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Time from dosing to minimum concentration at steady state (Tmin,ss ).
measure: AUCτ,ss
time frame: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.
description: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).
measure: λz,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Terminal rate constant in plasma at steady state (λz,ss ).
measure: t1/2,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).
measure: MRTpo,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Mean residence time of the analyte in the body at steady state (MRTpo,ss).
measure: CL/F,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).
measure: Vz/F,ss
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).
measure: Ae 0-12,ss
time frame: 12 hours after last study drug administration on day 1
description: Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).
measure: fe 0-12,ss
time frame: 12 hours after last study drug administration on day 1.
description: Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).
measure: CLR,ss
time frame: 12h after last study drug administration on day 1
description: Renal clearance of the analyte at steady state (CLR(0-12),ss ).
measure: PTF
time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
description: Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.
measure: Number of Patients With Drug Related Adverse Events
time frame: From first drug administration until 24 hours after last study drug administration, upto 48 days
description: Number of patients with adverse events due to study drug.
measure: Vital Signs (Systolic and Diastolic Blood Pressure)
time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.
description: Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).
measure: Vital Signs (Pulse Rate)
time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h
description: Vital signs (Pulse rate (both supine and after standing for 1 minute)).
arm group label: MIRAPEX® - low
arm group type: Experimental
arm group label: MIRAPEX® - medium
arm group type: Experimental
arm group label: MIRAPEX® - high
arm group type: Experimental
intervention type: Drug
intervention name: MIRAPEX® - low
arm group label: MIRAPEX® - low
intervention type: Drug
intervention name: MIRAPEX® - medium
arm group label: MIRAPEX® - medium
intervention type: Drug
intervention name: MIRAPEX® - high
arm group label: MIRAPEX® - high
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Psychomotor Agitation
mesh term: Restless Legs Syndrome
mesh term: Syndrome
mesh term: Pramipexole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 