Pharmacokinetic Study With Repeated Doses of Stalevo

Pharmacokinetics Clinical Trial

Official title:

Levodopa Concentration Profile After Repeated Doses of Stalevo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693862
• Other study ID #: 2939115
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2008
• Last updated: June 6, 2008
• Start date: December 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 72 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• levodopa, carbidopa, entacapone

• levodopa, carbidopa

Locations

Country	Name	City	State
Finland	NEURO	Helsinki
Finland	Pharmacokinetics laboratory/Department of Pharmacology and Toxicology	Kuopio
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		Blood samples collected frequently on day 4 of both periods	No