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
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
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