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
First published:
01/02/2024
Institution
Multiple centres: 38 centres are involved in the study

Contact details

Eisai Medical Information

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
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