Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

Oregon Health & Science University (OHSU)

Status and phase: Withdrawn; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Apomorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00758368

R01NS021062-21 (U.S. NIH Grant/Contract)

eIRB 2167 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Ambulatory Pump

Experimental group

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.

Treatment:

Drug: Apomorphine

Subcutaneous Injections

Active Comparator group

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.

Treatment:

Drug: Apomorphine