| June 5, 2008 |
| June 6, 2008 |
| December 2006 |
| April 2008 (final data collection date for primary outcome measure) |
| Pharmacokinetics [ Time Frame: Blood samples collected frequently on day 4 of both periods ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00693862 on ClinicalTrials.gov Archive Site |
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| Pharmacokinetic Study With Repeated Doses of Stalevo |
| Levodopa Concentration Profile After Repeated Doses of Stalevo |
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. |
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| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
| Pharmacokinetics |
- Drug: levodopa, carbidopa, entacapone
- Drug: levodopa, carbidopa
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| Completed |
| 19 |
| May 2008 |
| April 2008 (final data collection date for primary outcome measure) |
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.
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| Both |
| 30 Years to 72 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Finland |
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| NCT00693862 |
| Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma |
| 2939115 |
| Orion Corporation, Orion Pharma |
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| Study Director: |
Jutta Hänninen, M.Sc. |
Orion Corporation, Orion Pharma |
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| Orion Corporation, Orion Pharma |
| June 2008 |