Accident, TrafficERoADSNCT04480996
Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)
An observational study of Accident, Traffic, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accident, Traffic
- What is being tested?
- Drugs Responsible for Cognitive Side Effects
- How many people
- 500,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects
Who may be able to join
- 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)
Who cannot join
- Chronology not compatible between the drug and the road traffic accident
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14033
Véronique Lelong-Boulouard, PhD, PharmD, +33231064670, lelongboulouard-v@chu-caen.fr
About this study
Official title: 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).
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.
- Conditions
- Accident, Traffic
- Being tested
- Drugs Responsible for Cognitive Side Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs Responsible for Cognitive Side EffectsDrug
Also called Drugs Responsible for Pyschomotor Side Effects
identification of road traffic accidents associated with drugs responsible for psychomotor side effects
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Drugs Responsible for Cognitive Side Effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Identification of the population criteria (age, sex ...) having road accidents related to certain classes of drugs
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Mar 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accident, TrafficStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Lelong-Boulouard, PhD, PharmD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480996
- Sponsor's protocol ID
- Pharmaco 20200619
- Acronym
- ERoADS
- Status last verified
- Jun 2020
- First submitted
- 17 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)
- ClinicalTrials.gov ID
- NCT04480996
- Acronym / sponsor ID
- ERoADS / Pharmaco 20200619
- Conditions
- Accident, Traffic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Road traffic accidents with medicines | – | Drug: Drugs Responsible for Cognitive Side EffectsRoad 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated With Drugs Responsible for Cognitive and Psychomotor Side Effects
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the road traffic accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drugs Responsible for Cognitive Side EffectsAlso: Drugs Responsible for Pyschomotor Side Effectsidentification of road traffic accidents associated with drugs responsible for psychomotor side effects | Drug | Road traffic accidents with medicines |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 35939367Chretien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Lelong-Boulouard, PhD, PharmD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accident, Traffic, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique Lelong-Boulouard, PhD, PharmD (+33231064670, lelongboulouard-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.