Low Dose Apomorphine and Parkinsonism

Study Overview
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Brief Summary
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The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease.

Detailed Description
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The goal of the study is to learn why some people with Parkinson's disease (PD) get worse right after taking PD medication such as carbidopa/levodopa or as the medication is wearing off. In this study scientists will determine if apomorphine, a drug used to treat symptoms of PD, will worsen the motor symptoms of people with PD when low doses of the drug are given as a continuous subcutaneous infusion. A continuous subcutaneous infusion means the drug is administered continuously through a small needle placed under the skin. Apomorphine, a PD drug that works similar to carbidopa/levodopa, will be used in this study because it is faster-acting and has a more brief effect than carbidopa/levodopa. After the initial screening, participants will enter a 3-day treatment phase during which they will receive in random order low dose apomorphine, high dose apomorphine, or placebo (inactive substance). All participants will receive the study drug for 2 of the days at 2 different doses (low and high) and a placebo for 1 day. During the 3 days participants will provide blood samples and have their hearts monitored. Parkinsonism will be monitored each day by speed of finger tapping, foot tapping and walking as well as tremor and dyskinesia scores. Duration of the study for participants is approximately 4 to 5 days including 1-2 outpatient visits and a 3-day inpatient hospital stay.

Official Title
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Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: apomorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have idiopathic Parkinson's disease treated with levodopa and experiencing motor fluctuations Response to levodopa had to be documented by a 10 percent increase in finger or foot tapping speed Exclusion Criteria: Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases Psychosis Allergy to apomorphine or 5ht3 inhibitors Prolonged qt interval Pregnancy/breast-feeding Hemodynamic instability Severe nausea Alcohol/drug abuse Other unstable medical conditions

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: apomorphine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on parkinsonism measured with finger and foot tapping speed |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, PD, apomorphine