Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00758368
• Other study ID #: R01NS021062-21
• Secondary ID: R01NS021062-21eI
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Manson AJ, Turner K, Lees AJ. Apomorphine monotherapy in the treatment of refractory motor complications of Parkinson's disease: long-term follow-up study of 64 patients. Mov Disord. 2002 Nov;17(6):1235-41. — View Citation

Stocchi F, Ruggieri S, Vacca L, Olanow CW. Prospective randomized trial of lisuride infusion versus oral levodopa in patients with Parkinson's disease. Brain. 2002 Sep;125(Pt 9):2058-66. — View Citation

Stocchi F, Vacca L, Ruggieri S, Olanow CW. Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: a clinical and pharmacokinetic study. Arch Neurol. 2005 Jun;62(6):905-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in motor performance, measured as change in tapping speed during levodopa infusion		at baseline and after 6 months
Secondary	Improvement in "on" time, as measured by subject diaries		at baseline and after 6 months
Secondary	Reduction in levodopa and adjunct drug use		at baseline and after 6 months