Comparing the incidence of acute renal failure in patients with epilepsy exposed to levetiracetam versus other antiepileptic drugs

Study identification

• EU PAS number:
  EUPAS26595
• Study ID:
  44245
• Official title and acronym:
  Comparing the incidence of acute renal failure in patients with epilepsy exposed to levetiracetam versus other antiepileptic drugs
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is being conducted to compare the incidence of acute renal failure in patients with epilepsy exposed to levetiracetam versus other antiepileptic drugs in order to further review the association between exposure to levetiracetam and acute renal failure using real world data from a claim database in the US.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:15/11/2018

Actual:15/11/2018

Study start date

Planned:01/04/2020

Actual:01/04/2020

Data analysis start date

Planned:30/04/2020

Actual:30/04/2020

Date of final study report

Planned:30/06/2020

Actual:30/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB Pharma SA

Regulatory

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