Official Title: “A 3-Month, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs. Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing Off With Levodopa”

The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

The study will evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in patients with Parkinson's disease and early wearing off with levodopa

Intervention(s) in this Clinical Trial

• Drug: Levodopa/carbidopa/entacapona

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Levodopa/carbidopa/entacapone
• Active Comparator: 2
  • Levodopa/carbidopa

Primary Measures

• Unified Parkinson Disease Rating Scale score, Part II (Activities of daily living) at the beginning of the study and at 3 months

Secondary Measures

• Unified Parkinson Disease Rating Scale scores parts I (Mentation, behavior and mood), III (Motor examination), IV (Complications of the treatment) and total score at the beginning of the study and at 3 months
• Parkinson Disease Questionnaire-39 items at the beginning of the study and at 3 months
• Global assessments of the treatment, by patient and investigator, at baseline and 3 months

Inclusion Criteria:

• 1. Male and female patients ages ≥ 30 and ≤ 80 years old.
• 2. A clinical diagnosis of idiopathic Parkinson's disease.
• 3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
• 4. 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.
• 5. Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
• 6. Must have a minimum UPDRS part II (ADL) score of 9.
• 7. Patients without dyskinesia or with mild dyskinesia.
• 8. Female patients must be either post-menopausal or using one or more acceptable methods of contraception
• 9. 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:

• 1. Previous or current use of entacapone.
• 2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
• 3. Unstable Parkinson's disease patients
• 4. Patients who experience severe dyskinesia
• 5. 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)
• 6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
• 7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
• 8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit
• 9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis
• 10. Participated in another trial of an investigational drug/device within the last 30 days prior to study entry
• 11. Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Eduard Tolosa-Sarró, Dr. Principal Investigator Hospital Clínic i Provincial de Barcelona  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00391898

Study ID Number: CELC200AES03

ClinicalTrials.gov Identifier: NCT00391898

Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios. Ministerio de Sanidad y Consumo