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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001931 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: N-0923 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease |
| Estimated Enrollment: | 20 |
| Study Start Date: | May 1999 |
| Estimated Study Completion Date: | January 2001 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 990104, 99-N-0104 |
| Study First Received: | July 31, 2007 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001931 History of Changes |
| Health Authority: | United States: Federal Government |
|
Continuous Stimulation Dose Finding Skin Patch |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Agonists Pharmacologic Actions Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders N 0437 |
