Low Dose Apomorphine and Parkinsonism

Sponsor

Oregon Health and Science University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00472355

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: apomorphine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?

Actual Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Effects on parkinsonism measured with finger and foot tapping speed []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road	Portland	Oregon	United States	97239

Sponsors and Collaborators

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

Investigators

Principal Investigator: John G. Nutt, MD, Professor of Neurology, Oregon Health and Science University
Principal Investigator: Steven Gunzler, MD, Fellow and Clinical Instructor in Neurology, Oregon Health and Science University