Low Dose Apomorphine and Parkinsonism | NCT00472355

Studies
Low Dose Apomorphine and Parkinsonism

NCT00472355

Sponsor

Oregon Health and Science University

Status

Withdrawn

Last Update Posted

Nov 29, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

apomorphine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M01RR000334	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient study materials

Expanded Access Info

Start Date

Oct 2005Actual

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

May 10, 2007

First Submission Date that Met QC Criteria

May 10, 2007

First Posted Date

May 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2018

Last Update Posted Date

Nov 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John G. Nutt, Professor of Neurology, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

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

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
apomorphine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects on parkinsonism measured with finger and foot tapping speed

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road		Portland	Oregon	97239	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18268187	Derived	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D001060	Aporphines
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds