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Pharmacokinetic Study With Repeated Doses of Stalevo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693862
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693862


Locations
Finland
NEURO
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
Investigators
Study Director: Jutta Hänninen, M.Sc. Orion Corporation, Orion Pharma
  More Information

Responsible Party: Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00693862     History of Changes
Other Study ID Numbers: 2939115
First Submitted: June 5, 2008
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Levodopa
Carbidopa
Entacapone
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