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CompletedNCT00693862Updated Jun 9, 2008

Pharmacokinetic Study With Repeated Doses of Stalevo

A Phase 1 interventional study of levodopa, carbidopa, entacapone and levodopa, carbidopa in Pharmacokinetics, sponsored by Orion Corporation, Orion Pharma. Completed at 3 sites in Finland. Open to participants aged 30 Years to 72 Years. Per ClinicalTrials.gov, last updated 2008-06-09.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
30 Years to 72 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pharmacokinetics

Keywords

  • Focus of the study is pharmacokinetics of the study drug
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 72 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Stalevo

    Drug: levodopa, carbidopa, entacapone

  • Active comparator
    levodopa/carbidopa

    Drug: levodopa, carbidopa

Interventions

  • Druglevodopa, carbidopa, entacapone
  • Druglevodopa, carbidopa
06

What researchers measure

Primary outcomes

  1. Pharmacokinetics

    Time frame: Blood samples collected frequently on day 4 of both periods

07

Study locations

3 sites
  • NEURO
    Helsinki, 00250, Finland
  • Pharmacokinetics laboratory/Department of Pharmacology and Toxicology
    Kuopio, 70211, Finland
  • Turku University Hospital
    Turku, 20521, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693862
Lead sponsor
Orion Corporation, Orion Pharma
First posted
Jun 9, 2008
Start date
Dec 2006
Primary completion
Apr 2008
Completion
May 2008
Last update
Jun 9, 2008

Study contacts

Jutta Hänninen, M.Sc.
study director · Orion Corporation, Orion Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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