<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/NCT03034538</url>
  </required_header>
  <id_info>
    <org_study_id>15-179</org_study_id>
    <nct_id>NCT03034538</nct_id>
  </id_info>
  <brief_title>An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease</brief_title>
  <official_title>An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cooper Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cooper Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with&#xD;
      Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate&#xD;
      clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined&#xD;
      by number of subjects able to complete the study on their originally assigned dosage.&#xD;
      Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised&#xD;
      of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week&#xD;
      measurements. Additional analysis of the effect of Zonisamide on quality of life will be&#xD;
      measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Site staffing&#xD;
  </why_stopped>
  <start_date type="Actual">April 8, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unified Dyskinesia Rating Scale (UDysRS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>assesses involuntary movements encountered in the treatment of Parkinson's Disease. It consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Quality of Life Questionnaire (PDQ-39)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Parkinsonism</condition>
  <condition>Dyskinesias</condition>
  <arm_group>
    <arm_group_label>100mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zonegran 100mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zonegran 200mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zonegran</intervention_name>
    <description>100mg</description>
    <arm_group_label>100mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zonegran</intervention_name>
    <description>200mg</description>
    <arm_group_label>200mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of PD&#xD;
&#xD;
          -  Identified dyskinesias of the limbs or trunk as agreed upon by subject and&#xD;
             investigator, with dyskinesias considered moderately to completely disabling (UPDRS&#xD;
             question 33, greater or equal to 2)&#xD;
&#xD;
          -  Able to provide informed consent and swallow capsules&#xD;
&#xD;
          -  Stable doses of dopaminergic therapy for 2 weeks before and expected throughout the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atypical parkinsonism&#xD;
&#xD;
          -  Concurrent use of amantadine or active DBS where patient has some control over&#xD;
             settings&#xD;
&#xD;
          -  Prior surgery for PD&#xD;
&#xD;
          -  Sulfa allergy or intolerance of zonisamide&#xD;
&#xD;
          -  Significant concomitant medical illness in the opinion of the Principal Investigator&#xD;
             (renal disease, liver disease)&#xD;
&#xD;
          -  Pregnant subject or a subject who plans to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cooper University Health System</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2021</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>
    <mesh_term>Dyskinesias</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zonisamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034538
org study id: 15-179
nct id: NCT03034538
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with
      Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate
      clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined
      by number of subjects able to complete the study on their originally assigned dosage.
      Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised
      of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week
      measurements. Additional analysis of the effect of Zonisamide on quality of life will be
      measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Unified Dyskinesia Rating Scale (UDysRS)
time frame: 12 weeks
description: assesses involuntary movements encountered in the treatment of Parkinson's Disease. It consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment.
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
time frame: 12 weeks
description: The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.
arm group label: 100mg
arm group type: Active Comparator
description: Zonegran 100mg
arm group label: 200mg
arm group type: Active Comparator
description: Zonegran 200mg
intervention type: Drug
intervention name: Zonegran
description: 100mg
arm group label: 100mg
intervention type: Drug
intervention name: Zonegran
description: 200mg
arm group label: 200mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dyskinesias
mesh term: Parkinsonian Disorders
mesh term: Zonisamide
sharing ipd: No