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Status unknownNCT04480996ERoADSUpdated Jul 22, 2020

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

An observational study in Accident, Traffic, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
500,000
Ages
18 Years and older
Sex
All
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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).

Read the 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.

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Conditions studied

  • Accident, Traffic
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In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
500,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugDrugs Responsible for Cognitive Side Effects

    identification of road traffic accidents associated with drugs responsible for psychomotor side effects

    Also known as: Drugs Responsible for Pyschomotor Side Effects

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What researchers measure

Primary outcomes

  1. Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases

    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

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020

Secondary outcomes

  1. Association between two drugs of the same class, leading to an over-reporting of road traffic accidents

    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

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020

  2. Description of the population of patients having a road traffic accident related to taking medication

    Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020

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Study locations

1 of 1 sites recruiting
  • Caen University Hospital, Department of Pharmacology
    Caen, Normandie 14033, France
    Recruiting
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References and documents

Publications

  • Chretien B, Nguyen S, Dolladille C, Morice PM, Heraudeau M, Loilier M, Fedrizzi S, Bourgine J, Cesbron A, Alexandre J, Bocca ML, Freret T, Lelong-Boulouard V. Association between road traffic accidents and drugs belonging to the antiseizure medications class: A pharmacovigilance analysis in VigiBase. Br J Clin Pharmacol. 2023 Jan;89(1):222-231. doi: 10.1111/bcp.15481. Epub 2022 Aug 21. PubMed 35939367 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04480996
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jul 22, 2020
Start date
Mar 1, 2020
Primary completion
Dec 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Jul 22, 2020

Study contacts

Véronique Lelong-Boulouard, PhD, PharmD
Contact
lelongboulouard-v@chu-caen.fr
+33231064670
Véronique Lelong-Boulouard, PhD, PharmD
principal investigator · CHU Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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