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

Last updated: July 17, 2020
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04480996
Pharmaco 20200619
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Case reported in the World Health Organization (WHO) database of individual safetycase 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 thatcan induce cognitive and pyschomotor undesirable effects by crossing the blood-brainbarrier (ATC class A04, C02A, L)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500000
Study Start date:
March 01, 2020
Estimated Completion Date:
June 01, 2023

Study 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.

Connect with a study center

  • Caen University Hospital, Department of Pharmacology

    Caen, Normandie 14033
    France

    Active - Recruiting

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