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Low Dose Apomorphine and Parkinsonism

Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00472355
Enrollment
0
Registered
2007-05-11
Start date
2005-10-31
Completion date
2007-05-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, PD, apomorphine

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.

Interventions

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effects on parkinsonism measured with finger and foot tapping speed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026