Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

Inclusion Criteria

• Male and female patients ages ≥ 30 and ≤ 80 years old.
• A clinical diagnosis of idiopathic Parkinson's disease.
• Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
• Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
• 1 full tablet, and/or
• 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
• Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
• Must have a minimum UPDRS part II (ADL) score of 9.
• Patients without dyskinesia or with mild dyskinesia.
• Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
• Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria

• Previous or current use of entacapone.
• History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
• Unstable Parkinson's disease patients.
• Patients who experience severe dyskinesia.
• The following levodopa/carbidopa doses and strengths are not permitted:
• Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
• Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
• Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
• Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
• Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
• Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
• Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
• Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
• Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.