Clinical investigation of medicinal products for treatment of migraine - Scientific guideline Human Scientific guidelines
Page contentsPage contents Current effective version Document history Related content Topics This document provides guidance on the clinical development of new medicinal products in the treatment of migraine. Keywords: Migraine, acute migraine, chronic migraine, migraine prophylaxis Current effective version Guideline on clinical investigation of medicinal products for the treatment of migraineAdopted Reference Number: CPMP/EWP/788/01 Rev. 1 Legal effective date: 31/07/2007 English (EN) (66.73 KB - PDF)First published: 24/01/2007 Last updated: 24/01/2007 View Document history Concept paper on the need for revision of the guideline on clinical investigation of medicinal product for the treatment of migraineDraft: consultation closed Consultation dates: 21/10/2016 to 31/01/2017 Reference Number: EMA/CHMP/179671/2016 English (EN) (84.58 KB - PDF)First published: 21/10/2016 Last updated: 21/10/2016 View Guideline on clinical investigation of medicinal products for the treatment of migraineAdopted Reference Number: CPMP/EWP/788/01 Rev. 1 Legal effective date: 31/07/2007 English (EN) (66.73 KB - PDF)First published: 24/01/2007 Last updated: 24/01/2007 View Overview of comments received on draft guideline on clinical investigation of medicinal products for the treatment of migraineReference Number: EMEA/CHMP/EWP/21477/2007 English (EN) (56.57 KB - PDF)First published: 24/01/2007 Last updated: 24/01/2007 View Draft guideline on clinical investigation of medicinal products for the treatment of migraineDraft: consultation closed Reference Number: CPMP/EWP/788/01 Rev. 1 English (EN) (77.46 KB - PDF)First published: 26/01/2006 Last updated: 26/01/2006 View Related content Clinical efficacy and safety: nervous system Directive 2001/83/EC Application with 1. Meta-analyses; 2. One pivotal study ICH E1 Population exposure: the extent of population exposure to assess clinical safety ICH E4 Dose response information to support drug registration 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 Multiplicity issues in clinical trials Pharmacokinetic studies in man Topics Scientific guidelines Share this page