- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693862
Pharmacokinetic Study With Repeated Doses of Stalevo
June 6, 2008 updated by: Orion Corporation, Orion Pharma
Levodopa Concentration Profile After Repeated Doses of Stalevo
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
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, 00250
- NEURO
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Kuopio, Finland, 70211
- Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
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Turku, Finland, 20521
- Turku University Hospital
-
-
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
30 years to 72 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent obtained
- Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms.
- Hoehn and Yahr stage 1-2.5 performed during the "ON" state.
- Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg.
- Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period.
- Age within 30-72 years, inclusive.
Exclusion Criteria:
- Secondary or atypical parkinsonism.
- Patients with moderate to marked wearing-off symptoms or any unpredictable "OFF"-periods.
- Patients with treatment-related peak-dose dyskinesia.
- Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks.
- Use of any iron preparations or other chelating agents.
- Patients with a history of a 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.
- History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
- Any abnormalities in laboratory values, vital signs or electrocardiogram (ECG) with clinical relevance.
- Patients using any antiparkinsonian drugs for rescue medication (including soluble levodopa formulations).
- Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
- Known hypersensitivity to active substances or to any of the excipients of the study drugs.
- Participation in other drug studies within 60 days prior to study entry
- Unsuitable veins for repeated venopuncture.
- Blood donation or loss of significant amount of blood within 60 days prior to the screening.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stalevo
|
|
ACTIVE_COMPARATOR: levodopa/carbidopa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics
Time Frame: Blood samples collected frequently on day 4 of both periods
|
Blood samples collected frequently on day 4 of both periods
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jutta Hänninen, M.Sc., Orion Corporation, Orion Pharma
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
December 1, 2006
Primary Completion (ACTUAL)
April 1, 2008
Study Completion (ACTUAL)
May 1, 2008
Study Registration Dates
First Submitted
June 5, 2008
First Submitted That Met QC Criteria
June 6, 2008
First Posted (ESTIMATE)
June 9, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 9, 2008
Last Update Submitted That Met QC Criteria
June 6, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2939115
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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