Treatment of Parkinson's Disease With a Transdermal Skin Patch - Tabular View

Tracking Information
First Received Date ^ICMJE	July 31, 2007
Last Updated Date	March 3, 2008
Start Date ^ICMJE	May 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatment of Parkinson's Disease With a Transdermal Skin Patch
Official Title ^ICMJE	Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety/Efficacy Study
Condition ^ICMJE	Parkinson Disease
Intervention ^ICMJE	Drug: N-0923
Study Arms / Comparison Groups
Publications *	Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44. Review. Chase TN, Engber TM, Mouradian MM. Contribution of dopaminergic and glutamatergic mechanisms to the pathogenesis of motor response complications in Parkinson's disease. Adv Neurol. 1996;69:497-501. Review. No abstract available. Bravi D, Mouradian MM, Roberts JW, Davis TL, Sohn YH, Chase TN. Wearing-off fluctuations in Parkinson's disease: contribution of postsynaptic mechanisms. Ann Neurol. 1994 Jul;36(1):27-31.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	January 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001931
Responsible Party
Study ID Numbers ^ICMJE	990104, 99-N-0104
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	June 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP