Risks of arrhythmias reporting with antiepileptics including Lamotrigine: a pharmacovigilance study in VigiBase®

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45560
• EU PAS number:
  EUPAS45559
• Study ID:
  45560
• Official title and acronym:
  Risks of arrhythmias reporting with antiepileptics including Lamotrigine: a pharmacovigilance study in VigiBase®
• DARWIN EU® study:
  No
• Study countries:
  France
• Study status:
  Ongoing

Research institutions and networks

Institutions

Toulouse University Hospital

Study timelines

Date when funding contract was signed

Actual: 02/02/2022

Study start date

Actual: 02/02/2022

Date of final study report

Planned: 08/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Study not financed

Study protocol

Initial protocol

Study protocol_Risks of arrhythmias Antiepileptics

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable