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| Tracking Information | |||||||||
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| First Received Date † | May 10, 2007 | ||||||||
| Last Updated Date | December 7, 2007 | ||||||||
| Start Date † | October 2005 | ||||||||
| Current Primary Outcome Measures † |
Effects on parkinsonism measured with finger and foot tapping speed | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00472355 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Low Dose Apomorphine and Parkinsonism | ||||||||
| Official Title † | Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism? | ||||||||
| Brief Summary | The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||||||
| Condition † | Parkinson's Disease | ||||||||
| Intervention † | Drug: apomorphine | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | Gunzler SA, Koudelka C, Carlson NE, Pavel M, Nutt JG. Effect of low concentrations of apomorphine on parkinsonism in a randomized, placebo-controlled, crossover study. Arch Neurol. 2008 Feb;65(2):193-8. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Completed | ||||||||
| Estimated Enrollment † | 14 | ||||||||
| Completion Date | May 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00472355 | ||||||||
| Responsible Party | John G. Nutt, MD, Professor of Neurology, Oregon Health and Science University | ||||||||
| Secondary IDs †† | M01RR000334 | ||||||||
| Study Sponsor † | Oregon Health and Science University | ||||||||
| Collaborators †† | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Investigators † |
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| Information Provided By | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Verification Date | December 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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