Clinical trial NCT00693862: Pharmacokinetic Study With Repeated Doses of Stalevo
Official title: Levodopa Concentration Profile After Repeated Doses of Stalevo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Focus of the study is pharmacokinetics of the study drug
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 dosing regimen.


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Blood samples collected frequently on day 4 of both periods
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: NEURO
city: Kuopio
country: Finland
facility: Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Jutta Hänninen, M.Sc.
role: STUDY_DIRECTOR
References: