Pharmacokinetic Study With Repeated Doses of Stalevo
Information source: Orion Corporation, Orion Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: levodopa, carbidopa, entacapone (Drug); levodopa, carbidopa (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Jutta Hänninen, M.Sc., Study Director, Affiliation: Orion Corporation, Orion Pharma
Summary
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.
Clinical Details
Official title: Levodopa Concentration Profile After Repeated Doses of Stalevo
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetics
Eligibility
Minimum age: 30 Years.
Maximum age: 72 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Turku University Hospital, Turku 20521, Finland
NEURO, Helsinki 00250, Finland
Pharmacokinetics laboratory/Department of Pharmacology and Toxicology, Kuopio 70211, Finland
Additional Information
Starting date: December 2006
Ending date: May 2008
Last updated: June 6, 2008
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