Clinical investigation of medicinal products for treatment of migraine - Scientific guideline

Guidance on the clinical development of new medicinal products in the treatment of migraine.

Keywords: migraine, aura, migraine day, cluster headache, acute treatment of attacks, prophylactic treatment

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of migraine - Revision 1

Adopted Reference Number: CPMP/EWP/788/01 Rev. 1 Legal effective date: 31/07/2007

Document history

Draft guideline on clinical investigation of medicinal products for the treatment of migraine and cluster headache - Revision 2

Draft: consultation open Consultation dates: 10/09/2026 to 31/01/2027 Reference Number: EMA/137055/2026 Rev. 2 Summary:

This second revision aims to cover recommendations for the clinical development of medicinal products for the treatment of acute migraine attacks and for migraine prophylaxis in episodic and chronic migraine. In addition, recommendations for both acute and prophylactic treatment of episodic and chronic Cluster Headache are provided.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Concept paper on the need for revision of the guideline on clinical investigation of medicinal product for the treatment of migraine

Draft: consultation closed Consultation dates: 21/10/2016 to 31/01/2017 Reference Number: EMA/CHMP/179671/2016

Guideline on clinical investigation of medicinal products for the treatment of migraine - Revision 1

Adopted Reference Number: CPMP/EWP/788/01 Rev. 1 Legal effective date: 31/07/2007

Overview of comments received on draft guideline on clinical investigation of medicinal products for the treatment of migraine

Reference Number: EMEA/CHMP/EWP/21477/2007

Draft guideline on clinical investigation of medicinal products for the treatment of migraine

Draft: consultation closed Reference Number: CPMP/EWP/788/01 Rev. 1