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.

Condition	Phase
Parkinson Disease	Phase II

Further Study Details: 

Expected Total Enrollment:  20

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.

Genders Eligible for Study:  Both

Criteria

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.

Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

Study ID Numbers:  990104; 99-N-0104
Record last reviewed:  June 22, 2000
Last Updated:  December 11, 2002
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001931
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08