Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338896

Enrollment

Registered

2011-04-20

Start date

2011-04-30

Completion date

2011-06-30

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Rotigotine, Neupro

Brief summary

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Interventions

DRUGRotigotine transdermal patch

8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Exclusion criteria

* Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such * Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis

Design outcomes

Primary

Measure	Time frame	Description
The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)	2 days of 24 hours patch application	The international patch adhesiveness score

Secondary

Measure	Time frame	Description
Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application	after 24 hours of patch application	The international patch adhesiveness score
Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application	after 24 hour of patch application	The international patch adhesiveness score

Countries

Austria, Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026