Parkinson's DiseasePhase 2NCT00472355
Low Dose Apomorphine and Parkinsonism
A Phase 2 study testing apomorphine in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- apomorphine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases
- Psychosis
- Allergy to apomorphine or 5ht3 inhibitors
- Prolonged qt interval
- Pregnancy/breast-feeding
- Hemodynamic instability
Show all 9Show fewer
- Severe nausea
- Alcohol/drug abuse
- Other unstable medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology, Oregon Health and Science University, Mail Code OP32, 3181 SW Sam Jackson Park Road
Portland, Oregon, 97239
About this study
Official title: Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinson's disease.
Read the 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
- Being tested
- apomorphine
- Keywords
- Parkinson's disease, PD, apomorphine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apomorphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on parkinsonism measured with finger and foot tapping speed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startOct 2005
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Insufficient study materials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John G. Nutt, Oregon Health and Science University
- Investigators
- John G. Nutt, MD, Principal investigator, Professor of Neurology, Oregon Health and Science UniversitySteven Gunzler, MD, Principal investigator, Fellow and Clinical Instructor in Neurology, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472355
- Sponsor's protocol ID
- R01NS021062
- Other IDs
- M01RR000334
- Status last verified
- Nov 2018
- First submitted
- 10 May 2007
- Last updated
- 29 Nov 2018
- Results posted
- No
Publications
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.
PubMed 18268187
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism?
- ClinicalTrials.gov ID
- NCT00472355
- Acronym / sponsor ID
- R01NS021062
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, PD, apomorphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient study materials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2005 (actual)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases
- Psychosis
- Allergy to apomorphine or 5ht3 inhibitors
- Prolonged qt interval
- Pregnancy/breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apomorphine | Drug | – |
Primary outcome
Effects on parkinsonism measured with finger and foot tapping speed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Derived from this study: PubMed 18268187Gunzler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G. Nutt, MD principal investigator
Professor of Neurology, Oregon Health and Science University
Steven Gunzler, MD principal investigator
Fellow and Clinical Instructor in Neurology, Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apomorphine in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on parkinsonism measured with finger and foot tapping speed. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00472355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.