Pharmacokinetic Study With Repeated Doses of Stalevo

NCT00693862 | Completed Phase 1

• 1 other identifier: 2939115
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Pharmacokinetics

Keywords

Focus of the study is pharmacokinetics of the study drug

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Blood samples collected frequently on day 4 of both periods

Study Arms (2)

Stalevo

EXPERIMENTAL

Drug: levodopa, carbidopa, entacapone

levodopa/carbidopa

ACTIVE COMPARATOR

Drug: levodopa, carbidopa

Interventions

levodopa, carbidopa, entacapone DRUG

Stalevo

levodopa, carbidopa DRUG

levodopa/carbidopa

Eligibility Criteria

• Age: 30 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (3)

NEURO

Helsinki, 00250, Finland

Location

Pharmacokinetics laboratory/Department of Pharmacology and Toxicology

Kuopio, 70211, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Interventions

Levodopa; Carbidopa; entacapone; carbidopa, levodopa drug combination

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Study Officials

• Jutta Hänninen, M.Sc.

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 9, 2008

Record last verified: 2008-06

Locations

FI (3)