Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambulatory Pump

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.

Group Type EXPERIMENTAL

Apomorphine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Apomorphine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Apokyn, apomorphine, apo-go pump

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No