A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Study identification

• EU PAS number:
  EUPAS105866
• Study ID:
  105877
• Official title and acronym:
  A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Italy

  Portugal

  Russian Federation

  Spain
• Study description:
  The main aim of the study was to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who were prescribed perampanel (for partial onset seizures POS with or without secondary generalization SG or for primary generalized tonic-clonic seizures PGTCS associated with idiopathic generalized epilepsy IGE) as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eisai

Multiple centres: 38 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:12/03/2020

Study start date

Actual:20/07/2020

Data analysis start date

Actual:12/01/2023

Date of final study report

Planned:30/06/2023

Actual:04/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eisai Ltd.

Regulatory

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

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT04252846