Low Dose Apomorphine and Parkinsonism
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: apomorphine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
John G. Nutt, MD, Principal Investigator, Affiliation: Professor of Neurology, Oregon Health and Science University
Steven Gunzler, MD, Principal Investigator, Affiliation: Fellow and Clinical Instructor in Neurology, Oregon Health and Science University
Summary
The purpose of this study is to determine if low doses of apomorphine worsen the motor
symptoms of Parkinson's disease.
Clinical Details
Official title: Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Effects on parkinsonism measured with finger and foot tapping speed
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
Minimum age: 35 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, United States
Additional Information
Starting date: October 2005
Ending date: May 2007
Last updated: December 7, 2007
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