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

NCT06247410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-05-01

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Rotigotine 8Mg/24Hrs Patch

Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Principal Investigators

  • Wolfgang Jost, Prof. Dr med · Parkinson-Klinik Ortenau GmbH & Co KG

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2021-10-30
Completion
2021-10-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247410 on ClinicalTrials.gov