Pharmacokinetic Study With Repeated Doses of Stalevo

NCT ID: NCT00693862

Last Updated: 2008-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-05-31

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.

Conditions

Pharmacokinetics

Keywords

Focus of the study is pharmacokinetics of the study drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stalevo

Group Type: EXPERIMENTAL

levodopa, carbidopa, entacapone

Intervention Type: DRUG

levodopa/carbidopa

Group Type: ACTIVE_COMPARATOR

levodopa, carbidopa

Intervention Type: DRUG

Interventions

levodopa, carbidopa, entacapone

Intervention Type: DRUG

levodopa, carbidopa

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Orion Corporation, Orion Pharma

Principal Investigators

Jutta Hänninen, M.Sc.

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

NEURO

Helsinki, , Finland

Pharmacokinetics laboratory/Department of Pharmacology and Toxicology

Kuopio, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

2939115

Identifier Type: -

Identifier Source: org_study_id