EVALUATING THE OCCURRENCE OF ADVERSE EVENTS AMONG PEDIATRIC PATIENTS EXPOSED TO INTRAVENOUS LACOSAMIDE (VIMPAT®) USING REAL WORLD DATA

Study identification

• EU PAS number:
  EUPAS32597
• Study ID:
  45234
• Official title and acronym:
  EVALUATING THE OCCURRENCE OF ADVERSE EVENTS AMONG PEDIATRIC PATIENTS EXPOSED TO INTRAVENOUS LACOSAMIDE (VIMPAT®) USING REAL WORLD DATA
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This will be a retrospective cohort study that will use data from the PEDSnet database to estimate the incidence of select medical events for 8 System Organ Classes and 3 Standardized MedDRA Queries terms and specific medical events included in these broad categories, and examine the effect of increasing intravenous (IV) Lacosamide (LCM) loading dose on the incidence of these select medical events. The study will also compare the incidence of the selected medical events in pediatric patient (aged ≥ 1 month <17 years) treated with higher IV LCM doses (including UCB’s defined loading dose) to the incidence of these events in pediatric patients treated with a recommended initial/maintenance IV LCM dose.
• Study status:
  Finalised

Research institutions and networks

Networks

PEDSNet

Study timelines

Date when funding contract was signed

Planned:18/09/2019

Actual:18/09/2019

Study start date

Planned:31/01/2020

Actual:31/01/2020

Data analysis start date

Planned:01/03/2020

Date of final study report

Planned:30/06/2020

Actual:14/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB BIOPHARMA SRL

Regulatory

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