A 3-month, Multi-center, 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

Novartis26 sites in 1 country95 target enrollmentOctober 2006

ConditionsParkinson's Disease

InterventionsLevodopa/carbidopa/entacapone Levodopa/carbidopa

DrugsLevodopa/carbidopa/entacapone Levodopa/carbidopa

Overview

Phase: Phase 4
Intervention: Levodopa/carbidopa/entacapone
Conditions: Parkinson's Disease
Sponsor: Novartis
Enrollment: 95
Locations: 26
Primary Endpoint: Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

June 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

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
•Patients without dyskinesia or with mild dyskinesia.
•Female patients must be either post-menopausal or using one or more acceptable methods of contraception.

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.

Arms & Interventions

Levodopa/carbidopa/entacapone

Intervention: Levodopa/carbidopa/entacapone

Levodopa/carbidopa

Intervention: Levodopa/carbidopa

Outcomes

Primary Outcomes

Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3

Time Frame: Baseline to end of study (Month 3)

The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.

Secondary Outcomes

Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3(Baseline to end of study (Month 3))
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3(Baseline to end of study (Month 3))
Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3(Baseline to end of study (Month 3))
Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3(Baseline to end of study (Month 3))
Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3(Baseline to end of study (Month 3))
Patient and Investigator Global Evaluation of the Patient(Baseline to end of study (Month 3))