<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/NCT04480996</url>
  </required_header>
  <id_info>
    <org_study_id>Pharmaco 20200619</org_study_id>
    <nct_id>NCT04480996</nct_id>
  </id_info>
  <brief_title>Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)</brief_title>
  <acronym>ERoADS</acronym>
  <official_title>Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving&#xD;
      skills and road traffic accidents. This study investigates reports of road traffic accident&#xD;
      for different class of drugs responsible for cognitive and psychomotor sides effects&#xD;
      (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health&#xD;
      Organization's (WHO) global database of individual safety case reports (VigiBase).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some medications are responsible of a wide range of cognitive and psychomotor side effects&#xD;
      that may make it unsafe to drive and lead to risks of road accidents .The investigators use&#xD;
      VigiBase, the World Health Organization (WHO) database of individual safety case reports, to&#xD;
      identify cases of road traffic accidents following treatment with different class of drugs&#xD;
      responsible for pyschomotor sides effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases</measure>
    <time_frame>Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020</time_frame>
    <description>Identification of cases with association between each individual of different class of drugs responsible for cognitive ans psychomotor side effects and road traffic accidents cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between two drugs of the same class, leading to an over-reporting of road traffic accidents</measure>
    <time_frame>Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020</time_frame>
    <description>Association between two drugs in the different class studied and road traffic accidents cases to search for a potential interaction between two drugs of the same class, leading to an over-reporting of road traffic accidents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the population of patients having a road traffic accident related to taking medication</measure>
    <time_frame>Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020</time_frame>
    <description>Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500000</enrollment>
  <condition>Accident, Traffic</condition>
  <arm_group>
    <arm_group_label>Road traffic accidents with medicines</arm_group_label>
    <description>Road traffic accidents cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Drugs Responsible for Cognitive and Psychomotor Side Effects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drugs Responsible for Cognitive Side Effects</intervention_name>
    <description>identification of road traffic accidents associated with drugs responsible for psychomotor side effects</description>
    <arm_group_label>Road traffic accidents with medicines</arm_group_label>
    <other_name>Drugs Responsible for Pyschomotor Side Effects</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case reported in the World Health Organization (WHO) database of individual safety&#xD;
             case reports to 01/03/2020&#xD;
&#xD;
          -  Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ)&#xD;
&#xD;
          -  Patients treated with at least one liable nervous system drugs (ATC class N) or that&#xD;
             can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain&#xD;
             barrier (ATC class A04, C02A, L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronology not compatible between the drug and the road traffic accident&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Véronique Lelong-Boulouard, PhD, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Véronique Lelong-Boulouard, PhD, PharmD</last_name>
    <phone>+33231064670</phone>
    <email>lelongboulouard-v@chu-caen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Caen University Hospital, Department of Pharmacology</name>
      <address>
        <city>Caen</city>
        <state>Normandie</state>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique Lelong-Boulouard, PhD, PharmD</last_name>
      <phone>+33231064670</phone>
      <email>lelongboulouard-v@chu-caen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04480996
org study id: Pharmaco 20200619
nct id: NCT04480996
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving
      skills and road traffic accidents. This study investigates reports of road traffic accident
      for different class of drugs responsible for cognitive and psychomotor sides effects
      (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health
      Organization's (WHO) global database of individual safety case reports (VigiBase).
Some medications are responsible of a wide range of cognitive and psychomotor side effects
      that may make it unsafe to drive and lead to risks of road accidents .The investigators use
      VigiBase, the World Health Organization (WHO) database of individual safety case reports, to
      identify cases of road traffic accidents following treatment with different class of drugs
      responsible for pyschomotor sides effects.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
description: Identification of cases with association between each individual of different class of drugs responsible for cognitive ans psychomotor side effects and road traffic accidents cases
measure: Association between two drugs of the same class, leading to an over-reporting of road traffic accidents
time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
description: Association between two drugs in the different class studied and road traffic accidents cases to search for a potential interaction between two drugs of the same class, leading to an over-reporting of road traffic accidents
measure: Description of the population of patients having a road traffic accident related to taking medication
time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
description: Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs
arm group label: Road traffic accidents with medicines
description: Road traffic accidents cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Drugs Responsible for Cognitive and Psychomotor Side Effects
intervention type: Drug
intervention name: Drugs Responsible for Cognitive Side Effects
description: identification of road traffic accidents associated with drugs responsible for psychomotor side effects
arm group label: Road traffic accidents with medicines
other name: Drugs Responsible for Pyschomotor Side Effects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Véronique Lelong-Boulouard, PhD, PharmD
role: Principal Investigator
affiliation: CHU Caen
last name: Véronique Lelong-Boulouard, PhD, PharmD
phone: +33231064670
email: lelongboulouard-v@chu-caen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor