Status:
COMPLETED
Pharmacokinetic Study With Repeated Doses of Stalevo
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Pharmacokinetics
Eligibility:
All Genders
30-72 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00693862
Start Date
December 1 2006
End Date
May 1 2008
Last Update
June 9 2008
Active Locations (3)
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1
NEURO
Helsinki, Finland, 00250
2
Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
Kuopio, Finland, 70211
3
Turku University Hospital
Turku, Finland, 20521