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

Accident, Traffic Clinical Trial

— ERoADS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04480996
• Other study ID #: Pharmaco 20200619
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2020
• Source: University Hospital, Caen
• Contact: Véronique Lelong-Boulouard, PhD, PharmD
• Phone: +33231064670
• Email: lelongboulouard-v[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500000
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accident, Traffic

Intervention

Drug:
• Drugs Responsible for Cognitive Side Effects
identification of road traffic accidents associated with drugs responsible for psychomotor side effects

Locations

Country	Name	City	State
France	Caen University Hospital, Department of Pharmacology	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Secondary	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	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Secondary	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	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020