Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline

Guidance on the development of medicinal products for the treatment of epileptic disorders.

Keywords: Epilepsy, seizures, anti-epileptic agents

Current effective version

Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2

Adopted Reference Number: CHMP/EWP/566/98 Rev.2/Corr

Document history - Revision 3

Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3

Adopted Reference Number: CHMP/EWP/566/98 Rev.3 Legal effective date: 30/09/2025

Overview of comments received on guideline on clinical investigation of medicinal products in the treatment of epileptic disorders (CHMP/EWP/566/98 Rev.3)

Reference Number: EMA/117925/2025

Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3

Draft: consultation closed Consultation dates: 10/11/2023 to 30/01/2024 Reference Number: CHMP/EWP/566/98 Rev. 3

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2

Draft: consultation closed Consultation dates: 25/10/2016 to 31/01/2017 Reference Number: EMA/CHMP/179692/2016

Document history - Revision 2

Overview of comments received on 'Guideline on Clinical Investigation of Medicinal Products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.2) - Revision 2

Reference Number: EMA/611366/2009

Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2

Draft: consultation closed Reference Number: CHMP/EWP/566/98 Rev. 2

Recommendation of revision of the note for guidance on clinical investigation of medicinal products in treatment of epileptic disorders (CPMP/EWP/566/98 Rev. 1) - Revision 2

Reference Number: EMEA/CHMP/EWP/453780/2007