Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

This study has been withdrawn prior to enrollment.
(Inadequate support to conduct the study)
Sponsor:
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00758368
First received: September 23, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in dyskinesia severity and duration during the levodopa infusion, measured with a clinical rating scale during two-hour levodopa infusion [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in motor performance, measured as change in tapping speed during levodopa infusion [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]
  • Improvement in "on" time, as measured by subject diaries [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]
  • Reduction in levodopa and adjunct drug use [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Apokyn, apomorphine, apo-go pump
Active Comparator: 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.
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.
Other Name: Apokyn, apomorphine, apo-go pump

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758368

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: John G. Nutt, MD Oregon Health and Science University
  More Information

Publications:
Responsible Party: John G. Nutt, MD, Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00758368     History of Changes
Other Study ID Numbers: R01NS21062_21, R01NS21062-21, eIRB 2167
Study First Received: September 23, 2008
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
Parkinson's disease
PD
pulsatile apomorphine
dyskinesia
apomorphine
continuous dopaminergic stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Apomorphine
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014