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Low Dose Apomorphine and Parkinsonism

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ClinicalTrials.gov Identifier: NCT00472355
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : September 4, 2009
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Oregon Health and Science University

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: apomorphine Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
Study Start Date : October 2005
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Effects on parkinsonism measured with finger and foot tapping speed


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( U.S. NIH Grant/Contract )
M01RR000334 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

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
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action