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Pharmacokinetic Study With Repeated Doses of Stalevo

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008
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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levodopa Concentration Profile After Repeated Doses of Stalevo

Resource links provided by NLM:

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 ]

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
Experimental: Stalevo Drug: levodopa, carbidopa, entacapone
Active Comparator: levodopa/carbidopa Drug: levodopa, carbidopa


Ages Eligible for Study:   30 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00693862

Helsinki, Finland, 00250
Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
Kuopio, Finland, 70211
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Study Director: Jutta Hänninen, M.Sc. Orion Corporation, Orion Pharma
  More Information

Responsible Party: Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma Identifier: NCT00693862     History of Changes
Other Study ID Numbers: 2939115
Study First Received: June 5, 2008
Last Updated: June 6, 2008

Keywords provided by Orion Corporation, Orion Pharma:
Focus of the study is pharmacokinetics of the study drug

Additional relevant MeSH terms:
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors processed this record on June 26, 2017