<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/NCT03034564</url>
  </required_header>
  <id_info>
    <org_study_id>16-159</org_study_id>
    <nct_id>NCT03034564</nct_id>
  </id_info>
  <brief_title>A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue 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>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo&#xD;
      for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's&#xD;
      Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well&#xD;
      as the impact of fatigue on daily functioning and activities, including socialization.&#xD;
      Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's&#xD;
      disease-specific health related quality over the last month in 8 different dimensions of&#xD;
      function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8&#xD;
      situations for which the subject will rate the likelihood of falling asleep. There will be a&#xD;
      screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and&#xD;
      telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of&#xD;
      informed consent, concomitant medication review, adverse event review, pill counts, vital&#xD;
      signs (including supine blood pressure), and outcome measurements. Telephone visits will&#xD;
      include review of informed consent, concomitant medication review, and adverse event review.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Site staffing&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parkinson's Disease Fatigue Scale</measure>
    <time_frame>Week 12</time_frame>
    <description>16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PDQ-39</measure>
    <time_frame>Week 12</time_frame>
    <description>a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale</measure>
    <time_frame>Week 12</time_frame>
    <description>a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Fatigue</condition>
  <condition>Parkinsonism</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active group started 100 mg TID, increased by 100 mg per interval (i.e. 100 TID) every 2 days till on 600 TID, or until intolerable dose is achieved at which time the next highest dose will be maintained (increments of 100 TID will be used).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dosing regimen identical to active group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Northera</intervention_name>
    <arm_group_label>1</arm_group_label>
    <other_name>Droxidopa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Parkinson's Disease&#xD;
&#xD;
          -  Have normal kidney function (determined at screening visit by blood sample analysis),&#xD;
             and no active medical diagnoses associated with fatigue&#xD;
&#xD;
          -  No orthostatic symptoms (i.e. light headedness, blurred vision, and/or muscle&#xD;
             weakness)&#xD;
&#xD;
          -  No objective orthostasis (significant drop in blood pressure when standing)&#xD;
&#xD;
          -  No supine hypertension (high blood pressure while laying down) judged to be of&#xD;
             clinical significance by the investigator&#xD;
&#xD;
          -  Well-controlled depression&#xD;
&#xD;
          -  Stable dopaminergic medication regimen for 6 weeks prior to screening&#xD;
&#xD;
          -  No concurrent use of fludrocortisone, midodrine, or other medications that may raise&#xD;
             blood pressure&#xD;
&#xD;
          -  PD Fatigue Scale Score of 50 or above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Atypical Parkinsonism (having symptoms that mimic PD without a PD&#xD;
             diagnosis)&#xD;
&#xD;
          -  Prior Intolerance of droxidopa&#xD;
&#xD;
          -  SNRI or TCA class (both antidepressant) medications (irrespective of indication)&#xD;
&#xD;
          -  Use of activating agents (amantadine, modafinil, methylphenidate and related&#xD;
             stimulants)&#xD;
&#xD;
          -  Significant cardiac disease history&#xD;
&#xD;
          -  Significant kidney disease history, or creatinine (a chemical found in the blood)&#xD;
             greater than 1.5 mg/dl at baseline&#xD;
&#xD;
          -  Poorly controlled depression&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Significant history of Gastro Intestinal disease that may interfere with absorption&#xD;
             (gastric bypass, inflammatory bowel disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew McGarry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooper Health System</affiliation>
  </overall_official>
  <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 25, 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>Parkinsonian Disorders</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Droxidopa</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/NCT03034564
org study id: 16-159
nct id: NCT03034564
lead sponsor: 
This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo
      for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's
      Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well
      as the impact of fatigue on daily functioning and activities, including socialization.
      Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's
      disease-specific health related quality over the last month in 8 different dimensions of
      function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8
      situations for which the subject will rate the likelihood of falling asleep. There will be a
      screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and
      telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of
      informed consent, concomitant medication review, adverse event review, pill counts, vital
      signs (including supine blood pressure), and outcome measurements. Telephone visits will
      include review of informed consent, concomitant medication review, and adverse event review.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Parkinson's Disease Fatigue Scale
time frame: Week 12
description: 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization
measure: PDQ-39
time frame: Week 12
description: a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being
measure: Epworth Sleepiness Scale
time frame: Week 12
description: a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep
arm group label: 1
arm group type: Active Comparator
description: Active group started 100 mg TID, increased by 100 mg per interval (i.e. 100 TID) every 2 days till on 600 TID, or until intolerable dose is achieved at which time the next highest dose will be maintained (increments of 100 TID will be used).
arm group label: 2
arm group type: Placebo Comparator
description: Dosing regimen identical to active group
intervention type: Drug
intervention name: Northera
arm group label: 1
other name: Droxidopa
intervention type: Drug
intervention name: Placebo Oral Tablet
arm group label: 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew McGarry, MD
role: Principal Investigator
affiliation: Cooper Health System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Parkinsonian Disorders
mesh term: Fatigue
mesh term: Droxidopa