Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS) (ERoADS)

July 17, 2020 updated by: University Hospital, Caen

Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14033
        • Recruiting
        • Caen University Hospital, Department of Pharmacology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects

Description

Inclusion Criteria:

  • Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/03/2020
  • Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ)
  • Patients treated with at least one liable nervous system drugs (ATC class N) or that can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain barrier (ATC class A04, C02A, L)

Exclusion Criteria:

  • Chronology not compatible between the drug and the road traffic accident

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Road traffic accidents with medicines
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
Drug: Drugs Responsible for Cognitive Side Effects
identification of road traffic accidents associated with drugs responsible for psychomotor side effects
Other Names:
  • Drugs Responsible for Pyschomotor Side Effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
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
Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs
Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Véronique Lelong-Boulouard, PhD, PharmD, CHU Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Pharmaco 20200619

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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