Low Dose Apomorphine and Parkinsonism

Oregon Health & Science University (OHSU)

Status and phase

Withdrawn

Phase 2

Conditions

Parkinson's Disease

Treatments

Drug: apomorphine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00472355

R01NS021062 (U.S. NIH Grant/Contract)

M01RR000334 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

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