NCT04480996

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

July 17, 2020

Last Update Submit

July 17, 2020

Conditions

Accident, Traffic

Outcome Measures

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

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

Secondary Outcomes (2)

  • Association 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

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

Study Arms (1)

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

Drugs Responsible for Cognitive Side EffectsDRUG

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

Also known as: Drugs Responsible for Pyschomotor Side Effects
Road traffic accidents with medicines

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35939367DERIVED

Study Officials

  • Véronique Lelong-Boulouard, PhD, PharmD

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Lelong-Boulouard, PhD, PharmD

CONTACT

+33231064670lelongboulouard-v@chu-caen.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

July 22, 2020

Record last verified: 2020-06

Locations

FR(1)