Patch adhesiveness study

Rotigotine transdermal patches have currently been marketed in the European
Union and other countries. The patches are used for the treatment of patients
with Parkinson disease as well as for Restless Legs Syndrome . In both
Parkinson disease and Restless Legs Syndrome a shortage of the neurotransmitter
(messenger) Dopamine plays a role. In Parkinson disease this shortage results
in movement disorders, and in Restless Legs Syndrome results in an unpleasant
feeling in the legs that result In the urge to move the legs constantly.
However due to a change in the physical form of rotigotine, crystallization of
this substance occurs. Rotigotine works by stimulating these same receptor
sites as Dopamine, and therefore restoring the dopamine activity in the brain

The purpose of the study is to evaluate the adhesiveness of two different patch
formulations of rotigotine. This study is not intended to improve the health,
but is necessary for the further development of the rotigotine patches

Investigation of the adhesiveness of 2 different rotigotine formulation
patches, which will both be pllied on 2 different days for a period of 24
hours. This is a blinded study.

On day 1 and 2, two different rotigotine formulation patches will be apllied
for the duration of 24 hours. These patches will be removed on day 2 and 3 and
determined what the difference in adhesiveness is.

There might be adverse effects of the investigational procedures.

As the rotigotine patch is commercially available some common adverse effects
of rotigotine have been reported. The most reported adverse effects are
headache, nausea and vomiting, tiredness, decrease in ability to concentrate,
difficulty sleeping, feeling irritable, hypersensitivity, hyper-sexuality,
indigestion, increased blood pressure or low blood pressure at standing.

Since the use of the rotigotine patch can reduce the ability to concentrate and
react (due to sleepiness and sudden sleep attacks) driving the car should be
avoided until the sleepiness has been resolved.

As with other transdermal patch products, the use of patches may occasionally
lead to symptoms of contact dermatitis such as redness, rash, eruption, flare,
itching, pigmentation, skin irritation and loss of hair at the site of
application.

With the dose used in this study no serious adverse effects are expected. The
occurrence of known or other effects cannot be excluded. All potential drugs
cause adverse events to some extent. Therefore you should take into account
that some risks are still unknown at this moment