Clinical trial NCT00472355: Low Dose Apomorphine and Parkinsonism
Official title: Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
PD
apomorphine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2007-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Effects on parkinsonism measured with finger and foot tapping speed
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road
state: Oregon
Study officials:
affiliation: Professor of Neurology, Oregon Health and Science University
name: John G. Nutt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fellow and Clinical Instructor in Neurology, Oregon Health and Science University
name: Steven Gunzler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archneurol.2007.58.