Low Dose Apomorphine and Parkinsonism

Parkinson's Disease Clinical Trial

Official title:

Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00472355
• Other study ID #: R01NS021062
• Secondary ID: M01RR000334
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2005
• Est. completion date: May 2007

Study information

• Verified date: November 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders

Intervention

Drug:
• apomorphine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on parkinsonism measured with finger and foot tapping speed