<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/NCT01725802</url>
  </required_header>
  <id_info>
    <org_study_id>ND0612/002</org_study_id>
    <nct_id>NCT01725802</nct_id>
  </id_info>
  <brief_title>A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients</brief_title>
  <official_title>A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeuroDerm Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NeuroDerm Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD&#xD;
      solution (ND0612) on the safety and PK profile of LD will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: single center, double-blind, randomized, placebo-controlled, crossover study.&#xD;
&#xD;
      Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered&#xD;
      via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the&#xD;
      treatments.&#xD;
&#xD;
      Population: Eight (8) PD subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and frequency of adverse events</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Incidence and frequency of adverse events&#xD;
Adverse events reporting related to the ND0612 application, local safety score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withdrawal rate</measure>
    <time_frame>2 days</time_frame>
    <description>Withdrawal rates and discontinuations due to adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC</measure>
    <time_frame>Up to 2 days</time_frame>
    <description>LD PK profile after oral LD dosing administered with or without ND0612:</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>levodopa and carbidopa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>levodopa and carbidopa solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to levodopa and carbidopa</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levodopa and carbidopa solution for SC administration</intervention_name>
    <arm_group_label>levodopa and carbidopa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo to levodopa and carbidopa</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with idiopathic Parkinson's disease&#xD;
&#xD;
          -  Subjects must experience motor fluctuations associated with LD/CD dosing&#xD;
&#xD;
          -  Modified Hoehn and Yahr stage &lt; 5&#xD;
&#xD;
          -  Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor&#xD;
             therapy&#xD;
&#xD;
          -  Women must be postmenopausal, surgically sterilized, or using adequate birth control.&#xD;
             Women of childbearing potential must have a negative pregnancy test (serum beta-HCG)&#xD;
             at screening.&#xD;
&#xD;
          -  Subjects must be age 30 or older.&#xD;
&#xD;
          -  Subjects must be willing and able to give informed consent.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a clinically significant or unstable medical or surgical condition&#xD;
&#xD;
          -  Subjects with clinically significant psychiatric illness.&#xD;
&#xD;
          -  Pre-menopausal women, not using birth control method.&#xD;
&#xD;
          -  Subjects who have taken experimental medications within 60 days prior to baseline.&#xD;
&#xD;
          -  Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g.,&#xD;
             pallidotomy, thalamotomy, transplantation and deep brain stimulation).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levodopa</mesh_term>
    <mesh_term>Carbidopa</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725802
org study id: ND0612/002
nct id: NCT01725802
lead sponsor: 
has dmc: No
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD
      solution (ND0612) on the safety and PK profile of LD will be examined.
Design: single center, double-blind, randomized, placebo-controlled, crossover study.

      Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered
      via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the
      treatments.

      Population: Eight (8) PD subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence and frequency of adverse events
time frame: up to 8 weeks
description: Incidence and frequency of adverse events
Adverse events reporting related to the ND0612 application, local safety score
measure: Withdrawal rate
time frame: 2 days
description: Withdrawal rates and discontinuations due to adverse events
measure: LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
time frame: Up to 2 days
description: LD PK profile after oral LD dosing administered with or without ND0612:
arm group label: levodopa and carbidopa
arm group type: Experimental
description: levodopa and carbidopa solution
arm group label: placebo to levodopa and carbidopa
arm group type: Placebo Comparator
description: saline
intervention type: Drug
intervention name: levodopa and carbidopa solution for SC administration
arm group label: levodopa and carbidopa
intervention type: Drug
intervention name: Placebo
arm group label: placebo to levodopa and carbidopa
other name: Saline
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Levodopa
mesh term: Carbidopa