Pharmacokinetic Study With Repeated Doses of Stalevo - Full Text View

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00693862

Purpose

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.

Condition	Intervention	Phase
Pharmacokinetics	Drug: levodopa, carbidopa, entacapone Drug: levodopa, carbidopa	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Levodopa Concentration Profile After Repeated Doses of Stalevo

Resource links provided by NLM:

Drug Information available for: Levodopa Carbidopa OR 611 Entacapone

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: Blood samples collected frequently on day 4 of both periods ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	December 2006
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stalevo: Experimental	Drug: levodopa, carbidopa, entacapone
levodopa/carbidopa: Active Comparator	Drug: levodopa, carbidopa

Eligibility

Ages Eligible for Study:	30 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693862

Locations

Finland
Turku University Hospital
Turku, Finland, 20521
NEURO
Helsinki, Finland, 00250
Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
Kuopio, Finland, 70211

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Study Director:

Jutta Hänninen, M.Sc.

Orion Corporation, Orion Pharma

More Information

No publications provided

Responsible Party:	Orion Corporation, Orion Pharma ( Jutta Hänninen, Clinical Study Manager )
Study ID Numbers:	2939115
Study First Received:	June 5, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00693862 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Orion Corporation, Orion Pharma:

Focus of the study is pharmacokinetics of the study drug

Study placed in the following topic categories:

Neurotransmitter Agents
Levodopa
Dopamine

Carbidopa
Dopamine Agents
Entacapone

Additional relevant MeSH terms:

Levodopa
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Carbidopa
Physiological Effects of Drugs
Antiparkinson Agents

Enzyme Inhibitors
Pharmacologic Actions
Entacapone
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009