Clinical investigation of medicinal products in the treatment of Parkinson's disease - Scientific guideline

This document provides guidance on the development for medicinal products for the treatment of Parkinson's disease. Read together with Questions and answers on additional clarification for inclusion criteria in the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease revision 2.

Keywords: Parkinson's disease, Parkinson, confirmatory trials

Current effective version

Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease

Adopted Reference Number: EMA/CHMP/330418/2012 rev. 2

Document history - Revision 3

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease

Draft: consultation closed Consultation dates: 30/11/2025 to 31/03/2026 Reference Number: EMA/322471/2025 Summary:

The proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of Parkison’s disease (EMA/CHMP/330418/2012 rev. 2, 7 July 2012).

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

Document history - Revision 2

Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease

Adopted Reference Number: EMA/CHMP/330418/2012 rev. 2

Document history - Revision 1

Guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease

Adopted Reference Number: CPMP/EWP/563/95 Rev.1 Legal effective date: 01/02/2009

Overview of comments received on draft guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease

Reference Number: EMEA/402021/2008

Draft guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease

Draft: consultation closed Reference Number: CPMP/EWP/563/95 Rev.1

Recommendation on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Alzheimer's disease (CPMP/EWP/553/95) - Revision 1

Reference Number: EMEA/CHMP/EWP/369929/2005