- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562198
PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding
June 12, 2008 updated by: Orion Corporation, Orion Pharma
Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study.
This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms.
The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4).
Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet.
After the wash-out the study drug on period 2 will be administered according to a crossover design.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Helsinki, Finland, 00029
- Helsinki University Hospital, Department of Neurology
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Oulu, Finland, 90220
- Oulu University Hospital, Department of Neurology
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Pori, Finland, 28100
- Porin Lääkäritalo
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Tampere, Finland, 33520
- FinnMedi Tutkimus Oy
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Turku, Finland, 20520
- CRST
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients with idiopathic Parkinson's disease according to the UK Brain Bank criteria.
- Predictable wearing-off symptoms with a response to standard release levodopa/carbidopa (200/50 mg)during the levodopa challenge test lasting for a minimum of 1.5 h and a maximum of 4 h.
- The magnitude of response (peak effect) in the levodopa challenge test is at least 30%. The magnitude of response is defined to be the difference between the baseline score and the lowest UPDRS III score during the levodopa challenge test.
- Hoehn and Yahr stage of at least 2.0 performed during the "ON" state.
- Treatment with at least 4 daily doses of levodopa/dopa decarboxylase inhibitor (DDCI) (± entacapone(Comtess® or Stalevo) with total daily levodopa dose in the range of 400-1200mg.
- Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication [dopamine agonists,monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with an approved dose], if any, for at least 2 weeks prior to period I.
- Written informed consent obtained.
- Age of 45-80 years, inclusive.
Exclusion Criteria:
- Secondary or atypical parkinsonism.
- Patients with any unpredictable "OFF"-periods.
- Patients with moderate to severe treatment-related peak-dose dyskinesia likely to affect the quality of brain magnetic resonance image (MRI) or positron emission tomography (PET) imaging.
- Failure to adequately respond to the levodopa (levodopa/carbidopa 200/50 mg) challenge test with the duration of response lasting less than 1.5 h or more than 4 h.
- Presence of a basal ganglia lesion in the MRI image or any other factor(s) that would make MRI or PET imaging likely to be unsatisfactory.
- Presence of any ferromagnetic objects that would make brain MRI imaging contraindicated.
- Patients with a history of laboratory abnormality consistent with, or clinically significant cardiovascular,pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness, which may influence the outcome of the study including the interpretation and usage of MRI and PET images for the study purposes.
- History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
- Severe hepatic impairment.
- Any abnormal electrocardiogram (ECG) finding with clinical relevance.
- Female patients of childbearing potential (menstruating or less than 2 years post-menopausal) if they are not using adequate contraception during the study (defined as hormonal contraception, intrauterine device or surgical sterilization) or female patients who are pregnant or lactating.
- Treatment with cabergoline.
- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
- Concomitant treatment with any drugs with antidopaminergic action (e.g. with D2 receptor blocking properties) less than two weeks or within five times the elimination half-life of a given drug prior to the first study drug administration. As an exception, the use of domperidone is allowed.
- Current, regular use of any iron preparation that cannot be interrupted for the duration of the study
- Patients who are likely to need a rescue dose of levodopa after the withdrawal from their own levodopa/DDCI ± entacapone medication prior to PET imaging.
- Known hypersensitivity to active study drug substances or to any of the excipients.
- Participation in other drug studies within 30 days prior to study entry.
- Blood donation or loss of significant amount of blood within 60 days prior to the screening.
- Any other condition that in the opinion of the investigator could create a hazard to the subject safety,endanger the study procedures or interfere with the interpretation of study results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Investigational drug Stalevo 200
|
Entacapone 200mg carbidopa 50mg
Sinemet 200mg/50mg once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference between the study drugs in change in striatal 11C-raclopride BP.Striatal 11C-raclopride BP will be determined with PET scans performed at baseline and from 2.5 to 3.5 h after the study drug administration.
Time Frame: Post-dosing PET scan
|
Post-dosing PET scan
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference between the study drugs in levodopa mean C2.5- 3.5h.
Time Frame: C 2.5-3.5h
|
C 2.5-3.5h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juha Rinne, Dr, Turku PET Centre, Turku, Finland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
November 19, 2007
First Submitted That Met QC Criteria
November 20, 2007
First Posted (Estimate)
November 21, 2007
Study Record Updates
Last Update Posted (Estimate)
June 16, 2008
Last Update Submitted That Met QC Criteria
June 12, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Catechol O-Methyltransferase Inhibitors
- Aromatic Amino Acid Decarboxylase Inhibitors
- Carbidopa
- Carbidopa, levodopa drug combination
- Entacapone
Other Study ID Numbers
- 2939121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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