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Pharmacokinetic Study With Repeated Doses of Stalevo

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. Identifier: NCT00693862
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 9, 2008
Information provided by:
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date June 9, 2008
Study Start Date  ICMJE December 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
Pharmacokinetics [ Time Frame: Blood samples collected frequently on day 4 of both periods ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study With Repeated Doses of Stalevo
Official Title  ICMJE Levodopa Concentration Profile After Repeated Doses of Stalevo
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: levodopa, carbidopa, entacapone
  • Drug: levodopa, carbidopa
Study Arms  ICMJE
  • Experimental: Stalevo
    Intervention: Drug: levodopa, carbidopa, entacapone
  • Active Comparator: levodopa/carbidopa
    Intervention: Drug: levodopa, carbidopa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00693862
Other Study ID Numbers  ICMJE 2939115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jutta Hänninen, M.Sc. Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP