Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia
Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease
Lead sponsor: Oregon Health and Science University
|Source||Oregon Health and Science University|
The purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.
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.
|Start Date||March 2009|
|Completion Date||June 2011|
|Primary Completion Date||June 2011|
Intervention type: Drug
Intervention name: Apomorphine
Description: 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.
Other name: Apokyn, apomorphine, apo-go pump
Inclusion Criteria: - idiopathic Parkinson's Disease - clear response to levodopa (sinemet) - "off" at least 20% of waking day - dyskinesias present for at least two hours of waking day - subject or caregiver able to master use of drug delivery system (injector pen or pump) Exclusion Criteria: - physical complications that would preclude safe participation - standing systolic BP of <80 - lack of tolerance or response to apomorphine - drug/alcohol abuse
- idiopathic Parkinson's Disease
- clear response to levodopa (sinemet)
- "off" at least 20% of waking day
- dyskinesias present for at least two hours of waking day
- subject or caregiver able to master use of drug delivery system (injector pen or pump)
- physical complications that would preclude safe participation
- standing systolic BP of <80
- lack of tolerance or response to apomorphine
- drug/alcohol abuse
Minimum age: 21 Years
Maximum age: N/A
Healthy volunteers: No
Responsible party type: Principal Investigator
Investigator affiliation: Oregon Health and Science University
Investigator full name: John G. Nutt
Investigator title: Professor of Neurology
|Has Expanded Access||No|
|Number Of Arms||2|
Arm group label: Ambulatory Pump
Arm group type: Experimental
Description: 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.
Arm group label: Subcutaneous Injections
Arm group type: Active Comparator
Description: 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.
|Study Design Info||
Intervention model: Parallel Assignment
Primary purpose: Treatment
Masking: None (Open Label)