Low Dose Apomorphine and Parkinsonism - Full Text View

Sponsor:	Oregon Health and Science University
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00472355

Purpose

The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease	Drug: apomorphine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Dopamine Apomorphine Apomorphine hydrochloride Apomorphine hydrochloride anhydrous

U.S. FDA Resources

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

Primary Outcome Measures:

Effects on parkinsonism measured with finger and foot tapping speed

Estimated Enrollment:	14
Study Start Date:	October 2005
Study Completion Date:	May 2007

Detailed Description:

The goal of the study is to learn why some people with Parkinson's disease (PD) get worse right after taking PD medication such as carbidopa/levodopa or as the medication is wearing off.

In this study scientists will determine if apomorphine, a drug used to treat symptoms of PD, will worsen the motor symptoms of people with PD when low doses of the drug are given as a continuous subcutaneous infusion. A continuous subcutaneous infusion means the drug is administered continuously through a small needle placed under the skin. Apomorphine, a PD drug that works similar to carbidopa/levodopa, will be used in this study because it is faster-acting and has a more brief effect than carbidopa/levodopa.

After the initial screening, participants will enter a 3-day treatment phase during which they will receive in random order low dose apomorphine, high dose apomorphine, or placebo (inactive substance). All participants will receive the study drug for 2 of the days at 2 different doses (low and high) and a placebo for 1 day. During the 3 days participants will provide blood samples and have their hearts monitored. Parkinsonism will be monitored each day by speed of finger tapping, foot tapping and walking as well as tremor and dyskinesia scores.

Duration of the study for participants is approximately 4 to 5 days including 1-2 outpatient visits and a 3-day inpatient hospital stay.

Eligibility

Ages Eligible for Study:	35 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have idiopathic Parkinson's disease treated with levodopa and experiencing motor fluctuations
Response to levodopa had to be documented by a 10 percent increase in finger or foot tapping speed

Exclusion Criteria:

Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases
Psychosis
Allergy to apomorphine or 5ht3 inhibitors
Prolonged qt interval
Pregnancy/breast-feeding
Hemodynamic instability
Severe nausea
Alcohol/drug abuse
Other unstable medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472355

Locations

United States, Oregon
Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	John G. Nutt, MD	Professor of Neurology, Oregon Health and Science University
Principal Investigator:	Steven Gunzler, MD	Fellow and Clinical Instructor in Neurology, Oregon Health and Science University

More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gunzler SA, Koudelka C, Carlson NE, Pavel M, Nutt JG. Effect of low concentrations of apomorphine on parkinsonism in a randomized, placebo-controlled, crossover study. Arch Neurol. 2008 Feb;65(2):193-8.

Responsible Party:	John G. Nutt, MD, Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00472355 History of Changes
Other Study ID Numbers:	R01NS021062, M01RR000334
Study First Received:	May 10, 2007
Last Updated:	September 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:

Parkinson's disease
PD
apomorphine

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
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 07, 2012