Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

NCT00758368 | Withdrawn Phase 2

• 2 other identifiers: R01NS021062-21eIRB 2167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; PD; pulsatile apomorphine; dyskinesia; apomorphine; continuous dopaminergic stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Ambulatory Pump

EXPERIMENTAL

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

Subcutaneous Injections

ACTIVE COMPARATOR

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

Interventions

Apomorphine 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.

Also known as: Apokyn, apomorphine, apo-go pump

Ambulatory Pump; Subcutaneous Injections

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• physical complications that would preclude safe participation
• standing systolic BP of \<80
• lack of tolerance or response to apomorphine
• drug/alcohol abuse

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related 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. doi: 10.1002/mds.10281.

  PMID: 12465062 BACKGROUND

• 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. doi: 10.1093/brain/awf214.

  PMID: 12183351 BACKGROUND

• 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. doi: 10.1001/archneur.62.6.905.

  PMID: 15956161 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Study Officials

• John G. Nutt, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 2, 2018

Record last verified: 2018-10

Locations

US (1)