NCT00472355

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

May 10, 2007

Last Update Submit

November 27, 2018

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasePDapomorphine

Outcome Measures

Primary Outcomes (1)

  • Effects on parkinsonism measured with finger and foot tapping speed

Interventions

apomorphineDRUG

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 18268187DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AporphinesBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

October 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

US(1)