Pharmacokinetic Study With Repeated Doses of Stalevo

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: levodopa, carbidopa, entacapone; Drug: levodopa, carbidopa

• Registration Number: NCT00693862
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Last Update Submitted: 2008-06-06
• Study First Posted: 2008-06-09
• Last Update Posted: 2008-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stalevo	levodopa, carbidopa, entacapone	-
levodopa/carbidopa	levodopa, carbidopa	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Blood samples collected frequently on day 4 of both periods

Trial Locations

Locations (3)

Pharmacokinetics laboratory/Department of Pharmacology and Toxicology; 🇫🇮 Kuopio, Finland

NEURO; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland