Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered yes to the following question: In your opinion, does this patient have dyskinesia? Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.

Time frame: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.

The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.

Time frame: Baseline to Week 156

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.

The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.

Time frame: Baseline, Week 6 and Week 130

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.

Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered yes to the following question: In your opinion, does this patient have dyskinesia?

Time frame: Baseline to Week 208

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.

Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.

Time frame: Baseline to Week 134

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.

Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.

Time frame: Baseline to end of study (134-208 weeks of treatment)

Population: The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.