<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/NCT02259049</url>
  </required_header>
  <id_info>
    <org_study_id>BHS-1056</org_study_id>
    <nct_id>NCT02259049</nct_id>
  </id_info>
  <brief_title>The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease</brief_title>
  <official_title>The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood&#xD;
      pressure fluctuations in individuals with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits.&#xD;
      The first visit will be without an intervention to establish a baseline of 24 hour BP&#xD;
      fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6&#xD;
      (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week&#xD;
      later the subject will repeat the same procedures with either supplement or placebo.&#xD;
&#xD;
      This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Early Phase 1</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>L-Tyrosine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>We will administer a sugar pill BID for 24 hours and record BP and HR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>L-tyrosine</intervention_name>
    <description>Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.</description>
    <arm_group_label>L-Tyrosine</arm_group_label>
    <arm_group_label>Sugar Pill</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sugar Pill</intervention_name>
    <description>Each subject will receive a sugar pill BID for 24 hours.</description>
    <arm_group_label>L-Tyrosine</arm_group_label>
    <arm_group_label>Sugar Pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All subjects must have a diagnosis of PD by a licensed neurologist according to the UK&#xD;
             Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz,&#xD;
             2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion&#xD;
             criteria for diagnosing PD&#xD;
&#xD;
          2. between 35 and 79 years of age&#xD;
&#xD;
          3. mentally able to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. any person who is currently taking amino acid supplements.&#xD;
&#xD;
          3. Any history of myocardial infarction, stent, or CABG&#xD;
&#xD;
          4. Phenylketonurics&#xD;
&#xD;
          5. Untreated hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Donoghue, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Institute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Institute of Technology</name>
      <address>
        <city>Old Westbury</city>
        <state>New York</state>
        <zip>11758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>January 19, 2016</last_update_submitted>
  <last_update_submitted_qc>January 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York Institute of Technology</investigator_affiliation>
    <investigator_full_name>Joanne DiFrancisco-Donoghue</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02259049
org study id: BHS-1056
nct id: NCT02259049
lead sponsor: 
has dmc: No
The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood
      pressure fluctuations in individuals with Parkinson's disease.
We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits.
      The first visit will be without an intervention to establish a baseline of 24 hour BP
      fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6
      (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week
      later the subject will repeat the same procedures with either supplement or placebo.

      This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Blood Pressure
time frame: 24 hours
measure: Heart Rate
time frame: 24 hours
arm group label: L-Tyrosine
arm group type: Active Comparator
description: We will administer 1,000 mg of L-tyrosine BID for 24 hours and record BP and HR.
arm group label: Sugar Pill
arm group type: Placebo Comparator
description: We will administer a sugar pill BID for 24 hours and record BP and HR.
intervention type: Dietary Supplement
intervention name: L-tyrosine
description: Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.
arm group label: L-Tyrosine
arm group label: Sugar Pill
intervention type: Dietary Supplement
intervention name: Sugar Pill
description: Each subject will receive a sugar pill BID for 24 hours.
arm group label: L-Tyrosine
arm group label: Sugar Pill
criteria: 
gender: All
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: No
last name: Joanne Donoghue, PhD
role: Principal Investigator
affiliation: New York Institute of Technology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York Institute of Technology
investigator full name: Joanne DiFrancisco-Donoghue
investigator title: Associate Professor
mesh term: Parkinson Disease