<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/NCT01733199</url>
  </required_header>
  <id_info>
    <org_study_id>RC12_0059</org_study_id>
    <nct_id>NCT01733199</nct_id>
  </id_info>
  <brief_title>Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles</brief_title>
  <acronym>PARKADD</acronym>
  <official_title>Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <brief_summary>
    <textblock>
      This study is composed of a main study and an ancillary one. The objective of the main study&#xD;
      is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the&#xD;
      predictive factors for developing a behavioural addiction (BA) secondarily to the&#xD;
      dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in&#xD;
      patients with Parkinson's disease.&#xD;
&#xD;
      3 particular profiles of patients will be established:&#xD;
&#xD;
        -  BA- : no secondary behavioural addiction&#xD;
&#xD;
        -  BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome&#xD;
&#xD;
        -  BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome&#xD;
&#xD;
      We wish in particular:&#xD;
&#xD;
        -  To differentiate, among the BA+ subjects, those for who is a DDS from those for who we&#xD;
           can evoke a side effect of the dopaminergic treatment&#xD;
&#xD;
        -  To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities&#xD;
           causing the occurrence of the BA.&#xD;
&#xD;
        -  To clarify the possible relationship between the dosage and the pharmacodynamics of the&#xD;
           treatment (especially that of pramipexole) in one hand, and the developing of BA in the&#xD;
           other hand.&#xD;
&#xD;
        -  Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability&#xD;
           (related to the dopamine system), originally from the occurrence of the BA.&#xD;
&#xD;
      This study has several levels of evaluation, we chose describe the methodology of the study&#xD;
      in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.&#xD;
&#xD;
      The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary&#xD;
      study centered on the pharmacokinetic of the pramipexole (in its immediate release form).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a monocentric study with a recruitment period comprised between October 2012 and&#xD;
      April 2016. The recruitment occurs during the consultations in the service of neurology. If&#xD;
      the subjects are eligible, the study is proposed to them, and an evaluation is fixed in the&#xD;
      next days. This evaluation consists in an individual face-to-face interview based on&#xD;
      standardized and semi-structured questionnaires, during approximately one and a half hour.&#xD;
      It's focused on the different characteristics of Parkinson's disease, and on psychiatric and&#xD;
      addictive co morbidities. The evaluation is completed by a set of self-administered&#xD;
      questionnaires focused on impulsivity and Attention Deficit Hyperactivity Disorder (ADHD).&#xD;
&#xD;
      For the 80 patients participated to the ancillary study only, a blood sample will be realized&#xD;
      when the patient will arrived, just before the intake of his treatment (to obtain the&#xD;
      residual plasmatic concentration). A second sample will be realized at a different time for&#xD;
      each patient, to cover the entirety of the kinetic between 2 intakes of pramipexole&#xD;
      (immediate release form) via the entire sample. The second blood sample will be realized four&#xD;
      hours after the first one at the most. After this second sample, the patient will have&#xD;
      completed his participation to the study.&#xD;
&#xD;
      Secondly, monitoring including a self-questionnaire booklet and a saliva sample will be&#xD;
      offered to all patients who completed the initial visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire &quot;UPPS&quot;</measure>
    <description>This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacological axis : Area under the curve of the pramipexole concentration</measure>
    <description>Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score</measure>
    <description>UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genetic axis : distribution of allele frequencies and genotypic</measure>
    <description>Distribution of allele frequencies and genotypic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatments except the anti-parkinsonism ones</measure>
    <description>Psychopathological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>drug misuse</measure>
    <description>Psychopathological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>addiction and punding antecedents</measure>
    <description>Psychopathological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADHD antecedents</measure>
    <description>Psychopathological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impulsivity profile</measure>
    <description>Psychopathological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of onset of the Parkinson's disease</measure>
    <description>Neurological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stage and form of the Parkinson's disease</measure>
    <description>Neurological axis included dyskinesia and involuntary abnormal movements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time course of Parkinson's disease</measure>
    <description>Neurological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>family history of Parkinson's disease</measure>
    <description>Neurological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anti-parkinsonism treatments</measure>
    <description>Neurological axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual plasmatic concentration of the pramipexole</measure>
    <description>Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>median pharmacokinetic parameters of pramipexole</measure>
    <description>Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>study of the hepatic and renal functions</measure>
    <description>Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiopathological covariates</measure>
    <description>Pharmacological axis age, gender, weight, creatinine and prothrombin rates The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Secondary Behavioural Addiction</condition>
  <arm_group>
    <arm_group_label>BA-</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with no secondary behavioural addiction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA+/DDS-</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with secondary behavioural addiction, without dopamine dysregulation syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BA+/DDS+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with secondary behavioural addiction and dopamine dysregulation syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <description>Summons of patients and filling questionnaire.</description>
    <arm_group_label>BA+/DDS+</arm_group_label>
    <arm_group_label>BA+/DDS-</arm_group_label>
    <arm_group_label>BA-</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main study&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  To be 18 years old or more (both genders)&#xD;
&#xD;
          -  To have idiopathic Parkinson's disease, without important cognitive troubles, treated&#xD;
             by usually prescribed drugs&#xD;
&#xD;
          -  To have a treatment established since 6 months at least&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  To be under tutelage (a French protecting measure for persons with altered judgement)&#xD;
&#xD;
          -  To have a secondary Parkinson's disease&#xD;
&#xD;
          -  To have received a chirurgical treatment for Parkinson's disease&#xD;
&#xD;
          -  To present obvious cognitive disturbances&#xD;
&#xD;
        Ancillary study (pharmacokinetic axis) :&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  The same as the main study&#xD;
&#xD;
          -  To have a treatment by pramipexole in the immediate release form&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  The same as the main study&#xD;
&#xD;
          -  Association of the pramipexole with others molecules&#xD;
&#xD;
          -  To use to have a behavioural addiction resolved by a diminution of the dosage before&#xD;
             the study&#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>Marie GRALL-BRONNEC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes UH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>February 14, 2018</last_update_submitted>
  <last_update_submitted_qc>February 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Behavioural addictions</keyword>
  <keyword>Pathological gambling</keyword>
  <keyword>Dopamine agonist</keyword>
  <keyword>Dopamine dysregulation syndrome</keyword>
  <keyword>Pharmacokinetic</keyword>
  <keyword>Pramipexole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Behavior, Addictive</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/NCT01733199
org study id: RC12_0059
nct id: NCT01733199
lead sponsor: 
This study is composed of a main study and an ancillary one. The objective of the main study
      is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the
      predictive factors for developing a behavioural addiction (BA) secondarily to the
      dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in
      patients with Parkinson's disease.

      3 particular profiles of patients will be established:

        -  BA- : no secondary behavioural addiction

        -  BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome

        -  BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome

      We wish in particular:

        -  To differentiate, among the BA+ subjects, those for who is a DDS from those for who we
           can evoke a side effect of the dopaminergic treatment

        -  To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities
           causing the occurrence of the BA.

        -  To clarify the possible relationship between the dosage and the pharmacodynamics of the
           treatment (especially that of pramipexole) in one hand, and the developing of BA in the
           other hand.

        -  Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability
           (related to the dopamine system), originally from the occurrence of the BA.

      This study has several levels of evaluation, we chose describe the methodology of the study
      in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.

      The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary
      study centered on the pharmacokinetic of the pramipexole (in its immediate release form).
This is a monocentric study with a recruitment period comprised between October 2012 and
      April 2016. The recruitment occurs during the consultations in the service of neurology. If
      the subjects are eligible, the study is proposed to them, and an evaluation is fixed in the
      next days. This evaluation consists in an individual face-to-face interview based on
      standardized and semi-structured questionnaires, during approximately one and a half hour.
      It's focused on the different characteristics of Parkinson's disease, and on psychiatric and
      addictive co morbidities. The evaluation is completed by a set of self-administered
      questionnaires focused on impulsivity and Attention Deficit Hyperactivity Disorder (ADHD).

      For the 80 patients participated to the ancillary study only, a blood sample will be realized
      when the patient will arrived, just before the intake of his treatment (to obtain the
      residual plasmatic concentration). A second sample will be realized at a different time for
      each patient, to cover the entirety of the kinetic between 2 intakes of pramipexole
      (immediate release form) via the entire sample. The second blood sample will be realized four
      hours after the first one at the most. After this second sample, the patient will have
      completed his participation to the study.

      Secondly, monitoring including a self-questionnaire booklet and a saliva sample will be
      offered to all patients who completed the initial visit.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
description: This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.
measure: Pharmacological axis : Area under the curve of the pramipexole concentration
description: Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.
measure: Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
description: UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)
measure: Genetic axis : distribution of allele frequencies and genotypic
description: Distribution of allele frequencies and genotypic
measure: Treatments except the anti-parkinsonism ones
description: Psychopathological axis
measure: drug misuse
description: Psychopathological axis
measure: addiction and punding antecedents
description: Psychopathological axis
measure: ADHD antecedents
description: Psychopathological axis
measure: impulsivity profile
description: Psychopathological axis
measure: Age of onset of the Parkinson's disease
description: Neurological axis
measure: stage and form of the Parkinson's disease
description: Neurological axis included dyskinesia and involuntary abnormal movements
measure: time course of Parkinson's disease
description: Neurological axis
measure: family history of Parkinson's disease
description: Neurological axis
measure: anti-parkinsonism treatments
description: Neurological axis
measure: Residual plasmatic concentration of the pramipexole
description: Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
measure: median pharmacokinetic parameters of pramipexole
description: Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
measure: study of the hepatic and renal functions
description: Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
measure: Physiopathological covariates
description: Pharmacological axis age, gender, weight, creatinine and prothrombin rates The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
arm group label: BA-
arm group type: Experimental
description: Patient with no secondary behavioural addiction
arm group label: BA+/DDS-
arm group type: Experimental
description: Patients with secondary behavioural addiction, without dopamine dysregulation syndrome
arm group label: BA+/DDS+
arm group type: Experimental
description: Patients with secondary behavioural addiction and dopamine dysregulation syndrome
intervention type: Other
intervention name: questionnaires
description: Summons of patients and filling questionnaire.
arm group label: BA+/DDS+
arm group label: BA+/DDS-
arm group label: BA-
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie GRALL-BRONNEC
role: Principal Investigator
affiliation: Nantes UH
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Behavior, Addictive