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Treatment of Parkinson's Disease With a Transdermal Skin Patch

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001931
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 20
Study Start Date: May 1999
Estimated Study Completion Date: January 2001
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001931


Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001931     History of Changes
Other Study ID Numbers: 990104
99-N-0104
First Submitted: July 31, 2007
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: June 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Continuous Stimulation
Dose Finding
Skin Patch

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs