- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472355
Low Dose Apomorphine and Parkinsonism
Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
Study Overview
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effects on parkinsonism measured with finger and foot tapping speed
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Collaborators and Investigators
Investigators
- Principal Investigator: John G. Nutt, MD, Professor of Neurology, Oregon Health and Science University
- Principal Investigator: Steven Gunzler, MD, Fellow and Clinical Instructor in Neurology, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Parkinsonian Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- R01NS021062 (U.S. NIH Grant/Contract)
- M01RR000334 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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