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Clinical Trials/NCT00472355
NCT00472355
Withdrawn
Phase 2

Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Oregon Health and Science University1 site in 1 countryOctober 2005

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Oregon Health and Science University
Locations
1
Primary Endpoint
Effects on parkinsonism measured with finger and foot tapping speed
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
May 2007
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John G. Nutt

Professor of Neurology

Oregon Health and Science University

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

Outcomes

Primary Outcomes

Effects on parkinsonism measured with finger and foot tapping speed

Study Sites (1)

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