Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline
HumanScientific guidelines
This document provides 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
AdoptedReference Number: CHMP/EWP/566/98 Rev.2/Corr
English (EN) (248.78 KB - PDF)
First published: Last updated:
Document history - Revision 3
Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3
AdoptedReference Number: CHMP/EWP/566/98 Rev.3Legal effective date:
English (EN) (864.29 KB - PDF)
First published:
Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3
Draft: consultation closedConsultation dates:
to Reference Number: CHMP/EWP/566/98 Rev. 3
English (EN) (997.26 KB - PDF)
First published: Last updated:
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 closedConsultation dates:
to Reference Number: EMA/CHMP/179692/2016
English (EN) (109.97 KB - PDF)
First published: Last updated:
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
English (EN) (127.27 KB - PDF)
First published: Last updated:
Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2
Draft: consultation closedReference Number: CHMP/EWP/566/98 Rev. 2
English (EN) (200.42 KB - PDF)
First published: Last updated:
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
English (EN) (30.87 KB - PDF)
First published: Last updated:
Related content
- Clinical efficacy and safety: nervous system
- Directive 2001/83/EC
- Application with 1. Meta-analyses; 2. One pivotal study
- Choice of a non-inferiority margin
- Clinical trials in small populations
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E7 Studies in support of special populations: geriatrics - questions and answers
- ICH E8 General considerations for clinical studies
- ICH E9 statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
- Investigation of drug interactions
- Pharmacokinetic studies in man