Treatment of Parkinson's Disease With a Transdermal Skin Patch
Treatment of Parkinson's Disease With a Transdermal Skin Patch
Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This
 occurs as a result of destructive changes in an area of the brain responsible for making
 dopamine, the basal ganglia. Muscle tremors, rigidity of movement, shuffling footsteps,
 droopy posture, and a mask-like expression on the face characterize Parkinson's disease.

 This study is designed to determine the effects of a new drug, N-9023. The drug acts like
 dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian
 symptoms.

 The goals of this study are to find out whether N-9023 is useful in treating the signs and
 symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and
 effective.
The acute safety and antiparkinsonian efficacy of transdermally delivered N-0923 will be
 evaluated in patients with Parkinson's disease. This dopamine receptor agonist will be
 administered transdermally under double-blind conditions, in a rising dose paradigm.
 Antiparkinsonian activity will be quantified by means of standard rating scales. Possible
 adverse events will be assessed by appropriate clinical and laboratory tests.
All patients will carry a diagnosis of Parkinson's Disease based on the presence of a
 characteristic clinical history and neurological findings. Symptom severity will range from
 Hoehn & Yahr stage II-IV.

 Males and females between the ages 30-76 are eligible for the study.

 Initial emphasis will be on patients who are taking few or no other medications than
 levodopa for their Parkinson's disease.

 No presence or history of any medical condition that can reasonably be expected to subject
 the patient to unwarranted risk.

 No patients with a history of significant cardiac (myocardial infarction within 12 months
 prior to study, dysrhythmia; QTc intervals greater than 440 msec).

 No patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit
 of normal values for LFT's and creatinine respectively).

 No patients with evidence of other serious medical illness, a history of alcohol or drug
 abuse, those who have participated in an investigational trial within 28 days prior to
 study, and pregnant or nursing women or anyone not practicing effective means of birth
 control.