<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/NCT02233023</url>
  </required_header>
  <id_info>
    <org_study_id>248.342</org_study_id>
    <nct_id>NCT02233023</nct_id>
  </id_info>
  <brief_title>Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease</brief_title>
  <official_title>Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease</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 assess and compare the safety of long term oral treatment for Parkinson's Disease&#xD;
      with pramipexole versus bromocriptine or other dopamine agonists, by measuring&#xD;
      cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal&#xD;
      degeneration, in a matched pair design&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1998</start_date>
  <primary_completion_date type="Actual">June 2000</primary_completion_date>
  <phase>Phase 4</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>Incidence of drug related signs of retinal degeneration</measure>
    <time_frame>up to 8 months</time_frame>
    <description>based on the evaluation of assessors blind to the treatment allocation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of ophthalmological history</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of visual acuity</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of abnormal findings in clinical examination in miosis and mydriasis</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
    <description>including ophthalmoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of intraocular pressure (mmHg)</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of colour vision</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
    <description>using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Findings in kinetic perimetry</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with elevated dark adaptation thresholds</measure>
    <time_frame>within 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale</measure>
    <time_frame>within less than 2 months before ophthalmologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV</measure>
    <time_frame>within less than 2 months before ophthalmologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 2 month after neurologic visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Findings in standardised electroretinography (ERG)</measure>
    <time_frame>within 2 monhts after neurologic visit</time_frame>
    <description>performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">705</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Pramixpexole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bromocriptine and other dopamine agonists</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole</intervention_name>
    <arm_group_label>Pramixpexole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bromocriptine and other dopamine agonists</intervention_name>
    <arm_group_label>Bromocriptine and other dopamine agonists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with idiopathic Parkinson's Disease&#xD;
&#xD;
          -  Patients treated consecutively with either pramipexole or bromocriptine (or other&#xD;
             dopamine agonists except ropinirole) for at least two and a half years (i.e. 30&#xD;
             months). Interruptions of ongoing dopamine agonists treatment for less than one month&#xD;
             per year duration are acceptable, however, interruptions within the last 6 months are&#xD;
             not acceptable. Patients currently participating in ongoing open-label extension&#xD;
             trials with pramipexole may be included if they meet the requirement of 30 month&#xD;
             treatment&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice (GCP) and local&#xD;
             legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been treated less than two and a half years (i.e. 30 months) with&#xD;
             their actual dopamine agonist (regardless of the duration of treatment with a previous&#xD;
             dopamine agonist)&#xD;
&#xD;
          -  Patient treated with ropinirole&#xD;
&#xD;
          -  Patients with any of the following:&#xD;
&#xD;
               -  Patients with a hereditary retinal disease and/or a family history of hereditary&#xD;
                  retinal disease&#xD;
&#xD;
               -  Patients with a history of drug-induced retinopathies&#xD;
&#xD;
               -  Patients with a history of surgically or laser-treated diabetic retinopathy&#xD;
&#xD;
          -  Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders,&#xD;
             encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy,&#xD;
             multisystem atrophy)&#xD;
&#xD;
          -  Dementia or other disorders that could impair the signing of informed consent&#xD;
&#xD;
          -  Patients who are participating in other drug studies or who receive other&#xD;
             investigational drugs within 30 days prior to the first visit (patients currently&#xD;
             participating in ongoing open-label extension trials with pramipexole may be included&#xD;
             if they meet the requirement of 30 months treatment duration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</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>Dopamine</mesh_term>
    <mesh_term>Pramipexole</mesh_term>
    <mesh_term>Bromocriptine</mesh_term>
    <mesh_term>Dopamine Agonists</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/NCT02233023
org study id: 248.342
nct id: NCT02233023
lead sponsor: 
Study to assess and compare the safety of long term oral treatment for Parkinson's Disease
      with pramipexole versus bromocriptine or other dopamine agonists, by measuring
      cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal
      degeneration, in a matched pair design
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of drug related signs of retinal degeneration
time frame: up to 8 months
description: based on the evaluation of assessors blind to the treatment allocation
measure: Assessment of ophthalmological history
time frame: within 2 month after neurologic visit
measure: Assessment of visual acuity
time frame: within 2 month after neurologic visit
measure: Number of abnormal findings in clinical examination in miosis and mydriasis
time frame: within 2 month after neurologic visit
description: including ophthalmoscopy
measure: Assessment of intraocular pressure (mmHg)
time frame: within 2 month after neurologic visit
measure: Assessment of colour vision
time frame: within 2 month after neurologic visit
description: using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
measure: Findings in kinetic perimetry
time frame: within 2 month after neurologic visit
measure: Percentage of patients with elevated dark adaptation thresholds
time frame: within 2 month after neurologic visit
measure: Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
time frame: within less than 2 months before ophthalmologic visit
measure: Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV
time frame: within less than 2 months before ophthalmologic visit
measure: Number of patients with adverse events
time frame: up to 2 month after neurologic visit
measure: Findings in standardised electroretinography (ERG)
time frame: within 2 monhts after neurologic visit
description: performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard
arm group label: Pramixpexole
arm group type: Experimental
arm group label: Bromocriptine and other dopamine agonists
arm group type: Active Comparator
intervention type: Drug
intervention name: Pramipexole
arm group label: Pramixpexole
intervention type: Drug
intervention name: Bromocriptine and other dopamine agonists
arm group label: Bromocriptine and other dopamine agonists
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dopamine
mesh term: Pramipexole
mesh term: Bromocriptine
mesh term: Dopamine Agonists