<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/NCT03818243</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-421</org_study_id>
    <secondary_id>2018-A02417-48</secondary_id>
    <nct_id>NCT03818243</nct_id>
  </id_info>
  <brief_title>Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome</brief_title>
  <acronym>RLS nighfood</acronym>
  <official_title>Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigator have recently shown that Parkinson disease patients' with restless leg Syndrome&#xD;
      have more frequent impulse control behavior in particular compulsive feeding that patients&#xD;
      without Restless Leg Syndrome (RLS).&#xD;
&#xD;
      Investigator hypothesized that presence of RLS in parkinsonian patients could be a risk&#xD;
      factor for the emergence of TCI or associated behaviors, occurring preferentially at night.&#xD;
&#xD;
      The main objective of this study is to evaluate in patients with idiopathic Parkinson's&#xD;
      disease (IPD) the effect of the presence of a RLS on the evening compulsive eating behavior&#xD;
      by studying the circadian modulation of food intake of patients with RLS and impulse control&#xD;
      disorders.&#xD;
&#xD;
      For this investigator conduct a prospective study, with 2 groups of Parkinson disease&#xD;
      patients (with and without restless leg syndrome), to which investigator have to fill an&#xD;
      agenda to know the schedule of the behaviors during the day and the night.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type of study: prospective, case control study Number of center: 1 (Clermont Ferrand)&#xD;
&#xD;
      Patients:&#xD;
&#xD;
      The study will be performed in 60 patients with Parkinson disease (30 with RLS and 30 without&#xD;
      RLS)&#xD;
&#xD;
      Study Performance:&#xD;
&#xD;
      During the first visit (baseline, inclusion visit, 1 hour), each patient will perform an&#xD;
      interview about medical history and a neurological examination in order to identify RLS&#xD;
      (evaluation using the IRLSSG rating scale).&#xD;
&#xD;
        -  Parkinson disease severity will be assessed with the Movement Disorder Society-Sponsored&#xD;
           Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) and the Hoehn and&#xD;
           Yahr scale.&#xD;
&#xD;
        -  Cognitive assessment will be evaluated with the Montreal Cognitive assessment (MoCA)&#xD;
&#xD;
        -  Blood test to explore plasma ferritin, renal function and plasma glucose. A diary to&#xD;
           note all the impulse control behaviour will be given to each patient in order to be&#xD;
           completed for the next visit.&#xD;
&#xD;
      Finally, an actimetry system (a watch) will be also provided for each patient in order to&#xD;
      record the sleep-wake rhythm and to evaluate the quality and the duration of the sleep.&#xD;
&#xD;
      During the second visit (Baseline + 15 days), each patients will have :&#xD;
&#xD;
        -  a neuropsychological assessment (using the Ardouin scale of behavior in Parkinson's&#xD;
           disease ASBPD)&#xD;
&#xD;
        -  an evaluation of the night eating disorders :&#xD;
&#xD;
        -  The night eating syndrome will be evaluated with Night Eating Questionnaire (NEQ)&#xD;
&#xD;
        -  The Sleep related eating disorders will be evaluated with the International&#xD;
           classification of sleep disorders-third edition criteria&#xD;
&#xD;
        -  an evaluation of the Iimpulse control disorder using the questionnaire for&#xD;
           impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP RS).&#xD;
&#xD;
        -  A sleep and vigilance evaluation using the Epworth scale, the Parkinson's disease sleep&#xD;
           scale, the single-question screen for rapid eye movement sleep behavior disorder and the&#xD;
           REM sleep behavior disorder screening questionnaire.&#xD;
&#xD;
      Diary and actimetry will be recovered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">June 22, 2023</completion_date>
  <primary_completion_date type="Actual">June 16, 2022</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of daily night food intake measured at baseline + 15 day using the diary.</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with compulsive food intake measured at baseline + 15 day</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep caracteristics measured at baseline + 15 days using the accelerometry data</measure>
    <time_frame>at baseline + 15 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Restless Leg Syndrome</condition>
  <arm_group>
    <arm_group_label>RLS-</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with Parkinson disease without RLS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RLS+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with Parkinson disease with RLS</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diary (for reporting all impulse control disorders especially compulsive eating disorders)</intervention_name>
    <description>During 7 days, at home, patients must report in their diary all their impulse control disorders especially their compulsive eating disorders. They will detailed each food intake and drink intake and the time.</description>
    <arm_group_label>RLS+</arm_group_label>
    <arm_group_label>RLS-</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women, 18 to 80 years&#xD;
&#xD;
          -  Patients with a Parkinson disease (PD) with UKPDSBB criteria&#xD;
&#xD;
          -  with a medical treatment or other treatment, not modified 4 weeks before inclusion&#xD;
&#xD;
          -  Social security affiliation&#xD;
&#xD;
          -  Acceptance of the protocol and signature of a written consent&#xD;
&#xD;
        RLS group: Patients with IRLSSG criteria of RLS, with a frequency of RLS ≥ 2 times per week&#xD;
        Group without RLS: Patients without IRLSSG criteria of RLS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with an other neurological disease than Parkinson's disease&#xD;
&#xD;
          -  Patients with secondary RLS (other than Parkinson's disease)&#xD;
&#xD;
          -  Patients with psychiatric diseases&#xD;
&#xD;
          -  Patients with cognitive disorder (MoCA &lt;21)&#xD;
&#xD;
          -  Patients with body mass index &lt;16.5 or &gt;30&#xD;
&#xD;
          -  Patients with sleep-waking rhythm disorders (such as night work…)&#xD;
&#xD;
          -  Patients under trusteeship or guardianship or safeguarding of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana MARQUES</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson disease</keyword>
  <keyword>Restless Leg Syndrome</keyword>
  <keyword>Impulse control disorders</keyword>
  <keyword>circadian rhythm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Disruptive, Impulse Control, and Conduct Disorders</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/NCT03818243
org study id: CHU-421
secondary id: 2018-A02417-48
nct id: NCT03818243
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigator have recently shown that Parkinson disease patients' with restless leg Syndrome
      have more frequent impulse control behavior in particular compulsive feeding that patients
      without Restless Leg Syndrome (RLS).

      Investigator hypothesized that presence of RLS in parkinsonian patients could be a risk
      factor for the emergence of TCI or associated behaviors, occurring preferentially at night.

      The main objective of this study is to evaluate in patients with idiopathic Parkinson's
      disease (IPD) the effect of the presence of a RLS on the evening compulsive eating behavior
      by studying the circadian modulation of food intake of patients with RLS and impulse control
      disorders.

      For this investigator conduct a prospective study, with 2 groups of Parkinson disease
      patients (with and without restless leg syndrome), to which investigator have to fill an
      agenda to know the schedule of the behaviors during the day and the night.
Type of study: prospective, case control study Number of center: 1 (Clermont Ferrand)

      Patients:

      The study will be performed in 60 patients with Parkinson disease (30 with RLS and 30 without
      RLS)

      Study Performance:

      During the first visit (baseline, inclusion visit, 1 hour), each patient will perform an
      interview about medical history and a neurological examination in order to identify RLS
      (evaluation using the IRLSSG rating scale).

        -  Parkinson disease severity will be assessed with the Movement Disorder Society-Sponsored
           Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) and the Hoehn and
           Yahr scale.

        -  Cognitive assessment will be evaluated with the Montreal Cognitive assessment (MoCA)

        -  Blood test to explore plasma ferritin, renal function and plasma glucose. A diary to
           note all the impulse control behaviour will be given to each patient in order to be
           completed for the next visit.

      Finally, an actimetry system (a watch) will be also provided for each patient in order to
      record the sleep-wake rhythm and to evaluate the quality and the duration of the sleep.

      During the second visit (Baseline + 15 days), each patients will have :

        -  a neuropsychological assessment (using the Ardouin scale of behavior in Parkinson's
           disease ASBPD)

        -  an evaluation of the night eating disorders :

        -  The night eating syndrome will be evaluated with Night Eating Questionnaire (NEQ)

        -  The Sleep related eating disorders will be evaluated with the International
           classification of sleep disorders-third edition criteria

        -  an evaluation of the Iimpulse control disorder using the questionnaire for
           impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP RS).

        -  A sleep and vigilance evaluation using the Epworth scale, the Parkinson's disease sleep
           scale, the single-question screen for rapid eye movement sleep behavior disorder and the
           REM sleep behavior disorder screening questionnaire.

      Diary and actimetry will be recovered.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
primary purpose: Prevention
masking: None (Open Label)
masking description: no masking
measure: The percentage of daily night food intake measured at baseline + 15 day using the diary.
time frame: at baseline + 15 day
measure: Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary
time frame: at baseline + 15 day
measure: Percentage of patients with compulsive food intake measured at baseline + 15 day
time frame: at baseline + 15 day
measure: Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day
time frame: at baseline + 15 day
measure: Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days
time frame: at baseline + 15 day
measure: Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days
time frame: at baseline + 15 day
measure: sleep caracteristics measured at baseline + 15 days using the accelerometry data
time frame: at baseline + 15 day
arm group label: RLS-
arm group type: Experimental
description: patients with Parkinson disease without RLS
arm group label: RLS+
arm group type: Experimental
description: patients with Parkinson disease with RLS
intervention type: Behavioral
intervention name: Diary (for reporting all impulse control disorders especially compulsive eating disorders)
description: During 7 days, at home, patients must report in their diary all their impulse control disorders especially their compulsive eating disorders. They will detailed each food intake and drink intake and the time.
arm group label: RLS+
arm group label: RLS-
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ana MARQUES
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Psychomotor Agitation
mesh term: Restless Legs Syndrome
mesh term: Syndrome
mesh term: Disruptive, Impulse Control, and Conduct Disorders