Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Oregon Health and Science University National Institute of Neurological Disorders and Stroke (NINDS) |
---|---|
Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00758368 |
The purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: Apomorphine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia |
Estimated Enrollment: | 24 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Ambulatory Pump: Experimental
Participants will receive apomorphine via a pump. Participants in the Continuous Delivery Arm will self-administer apomorphine continuously (12-14 hours a day) using a portable pump.
|
Drug: Apomorphine
Participants in both arms will receive the study drug apomorphine for 6 months. One group will receive it continuously using a portable pump during waking hours, and the other group will receive it intermittently by bolus injections. The continuous delivery group will receive up to 100 mg apomorphine per 24 hours, delivered subcutaneously by ambulatory pump. The intermittent delivery group will receive up to 5 subcutaneous injections totaling up to 20 mg daily.
|
Subcutaneous Injections: Active Comparator
Participants will receive apomorphine via an injection pen. Participants in the Intermittent Delivery Arm will self-administer apomorphine at intervals, via a injection, using pen injector.
|
Drug: Apomorphine
Participants in both arms will receive the study drug apomorphine for 6 months. One group will receive it continuously using a portable pump during waking hours, and the other group will receive it intermittently by bolus injections. The continuous delivery group will receive up to 100 mg apomorphine per 24 hours, delivered subcutaneously by ambulatory pump. The intermittent delivery group will receive up to 5 subcutaneous injections totaling up to 20 mg daily.
|
Levodopa is a drug that can be taken by mouth, and improves the symptoms of Parkinson's disease (PD). However it can eventually cause involuntary movements called dyskinesia and motor fluctuations—fluctuations in the control of symptoms, often referred to as "off" and "on." Apomorphine is a drug that works as well as levodopa, but does not work if taken by mouth.
The purpose of this study is to compare the effects of apomorphine in people with PD who have levodopa-induced motor fluctuations and dyskinesias. In the trial, researchers will compare the effects of apomorphine administered by subcutaneous bolus injections (pulsatile) and by ambulatory infusion pumps (continuous) in 24 people with PD, for 6 months.
After an initial screening, potential participants will undergo a test to verify that they can tolerate and respond to apomorphine. Those who meet all of the requirements will be randomized to receive the study drug via injections (shots) using an injector pen or a portable infusion pump. Apomorphine will be given either continuously using the portable pump during the waking day or intermittently by injection, for 6 months. The pump will be carried on a belt and connected by a tube to a small needle under the skin. Injections of apomorphine under the skin will be self-administered by the participants or administered by friends or family members using injector pens.
After 6 months, the effects of apomorphine use will be assessed by measuring how the participants respond to levodopa and by measuring their symptoms during the course of the study. Participants will be followed initially every week, then biweekly, and then monthly in an outpatient clinic for 6 months. During this time, they may receive adjustments of apomorphine doses as well as doses of other antiparkinson medications.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erica Myruski, BSN, MPH | 503-494-9531 | myruski@ohsu.edu |
Contact: Penelope Hogarth, MD | (888) 222-6478 ext 49054 | hogarthp@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Erica Myruski, BSN, MPH 503-494-9531 myruski@ohsu.edu | |
Principal Investigator: John G. Nutt, MD | |
Sub-Investigator: Matthew Brodsky, MD | |
Sub-Investigator: Julie Carter, ANP | |
Sub-Investigator: Jeffrey Kraakevik, MD |
Principal Investigator: | John G. Nutt, MD | Oregon Health and Science University |
Responsible Party: | Oregon Health and Science University ( John G. Nutt, MD, Professor of Neurology ) |
Study ID Numbers: | R01NS21062_21, R01NS21062-21, eIRB 2167 |
Study First Received: | September 23, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00758368 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Parkinson's disease PD pulsatile apomorphine dyskinesia |
Neurotransmitter Agents Levodopa Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dopamine Agonists |
Dyskinesias Apomorphine Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Apomorphine Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |