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

Sponsors

Lead sponsor: Oregon Health and Science University

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Source Oregon Health and Science University
Brief Summary

The purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.

Detailed Description

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.

Overall Status Withdrawn
Start Date March 2009
Completion Date June 2011
Primary Completion Date June 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in dyskinesia severity and duration during the levodopa infusion, measured with a clinical rating scale during two-hour levodopa infusion at baseline and after 6 months
Secondary Outcome
Measure Time Frame
Improvement in motor performance, measured as change in tapping speed during levodopa infusion at baseline and after 6 months
Improvement in "on" time, as measured by subject diaries at baseline and after 6 months
Reduction in levodopa and adjunct drug use at baseline and after 6 months
Condition
Intervention

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

Eligibility

Criteria:

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
John G. Nutt, MD Principal Investigator Oregon Health and Science University
Location
facility Oregon Health and Science University
Location Countries

United States

Verification Date

October 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Oregon Health and Science University

Investigator full name: John G. Nutt

Investigator title: Professor of Neurology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

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

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov