Overview

Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease

Status:
COMPLETED
Trial end date:
2021-10-30
Target enrollment:
Participant gender:
Summary
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product. It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
Phase:
PHASE2
Details
Lead Sponsor:
SocraTec R&D GmbH
Collaborators:
Luye Pharma Group Ltd.
SocraMetrics GmbH
Treatments:
rotigotine