Low Dose Apomorphine and Parkinsonism

NCT ID: NCT00472355

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-05-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

apomorphine

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

John G. Nutt

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John G. Nutt, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Neurology, Oregon Health and Science University

Steven Gunzler, MD

Role: PRINCIPAL_INVESTIGATOR

Fellow and Clinical Instructor in Neurology, Oregon Health and Science University

Locations

Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road

Portland, Oregon, United States

Countries

United States

References

Gunzler SA, Koudelka C, Carlson NE, Pavel M, Nutt JG. Effect of low concentrations of apomorphine on parkinsonism in a randomized, placebo-controlled, crossover study. Arch Neurol. 2008 Feb;65(2):193-8. doi: 10.1001/archneurol.2007.58.

Reference Type: DERIVED

PMID: 18268187 (View on PubMed)

Other Identifiers

M01RR000334

Identifier Type: NIH

Identifier Source: secondary_id

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R01NS021062

Identifier Type: NIH

Identifier Source: org_study_id

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