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| Sponsors and Collaborators: |
Oregon Health and Science University National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00472355 |
Purpose
The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: apomorphine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism? |
| Estimated Enrollment: | 14 |
| Study Start Date: | October 2005 |
| Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |
| Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road | |
| Portland, Oregon, United States, 97239 | |
| 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 |
More Information
| Responsible Party: | Oregon Health and Science University ( John G. Nutt, MD, Professor of Neurology ) |
| Study ID Numbers: | R01NS021062, M01RR000334 |
| Study First Received: | May 10, 2007 |
| Last Updated: | December 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00472355 |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's disease PD apomorphine |
|
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Apomorphine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |
