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Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00219284
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : March 15, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease With End of Dose Wearing Off
Intervention Drug: Carbidopa/levodopa/entacapone
Enrollment 359
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch. Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Period Title: Treatment Phase - 16 Weeks
Started 180 179
Completed 136 128
Not Completed 44 51
Reason Not Completed
Adverse Event             26             24
Abnormal laboratory value(s)             0             1
Lack of Efficacy             3             10
Protocol Violation             9             5
Withdrawal by Subject             5             9
Lost to Follow-up             1             2
Period Title: Extension Phase - 8 Weeks
Started 114 [1] 106 [1]
Completed 112 99
Not Completed 2 7
Reason Not Completed
Adverse Event             2             3
Withdrawal by Subject             0             2
Lost to Follow-up             0             2
[1]
Not all subjects who completed the treatment phase chose to enter this optional extension phase.
Arm/Group Title Immediate Switch Delayed Switch Total
Hide Arm/Group Description Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch. Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch. Total of all reporting groups
Overall Number of Baseline Participants 180 179 359
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 179 participants 359 participants
68.7  (9.18) 68.3  (10.38) 68.5  (9.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 179 participants 359 participants
Female
74
  41.1%
71
  39.7%
145
  40.4%
Male
106
  58.9%
108
  60.3%
214
  59.6%
1.Primary Outcome
Title Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4
Hide Description Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 UPDRS part III scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.7  (0.66) -1.8  (0.58)
2.Secondary Outcome
Title Change in Parkinson’s Disease Quality of Life Score From Baseline to Week 4
Hide Description Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQUALIF scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 163 159
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.4  (0.88) 1.1  (0.77)
3.Secondary Outcome
Title Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8
Hide Description Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQUALIF scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 150 155
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.5  (1.01) -1.1  (0.89)
4.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8
Hide Description Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5-point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 UPDRS part III scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 146 152
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.6  (0.71) -3.7  (0.62)
5.Secondary Outcome
Title Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4
Hide Description The PDQ-39 is another instrument 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 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQ-39 scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 163 169
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.7  (1.34) 0.8  (1.17)
6.Secondary Outcome
Title Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8
Hide Description The PDQ-39 is another instrument 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 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQ-39 scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 150 155
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.8  (1.48) -1.9  (1.31)
7.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
Hide Description Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.
Time Frame Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment UPDRS part III scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 176 171
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.6  (0.69) -3.3  (0.64)
8.Secondary Outcome
Title Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment
Hide Description Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.
Time Frame Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQUALIF scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 176 172
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.3  (0.97) 0.2  (0.89)
9.Secondary Outcome
Title Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment
Hide Description The PDQ-39 is another instrument 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 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.
Time Frame Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQ-39 scores were included in the analysis.
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description:
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Overall Number of Participants Analyzed 176 172
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.8  (1.60) 0.4  (1.47)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Switch Delayed Switch
Hide Arm/Group Description Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch. Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
All-Cause Mortality
Immediate Switch Delayed Switch
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Switch Delayed Switch
Affected / at Risk (%) Affected / at Risk (%)
Total   8/180 (4.44%)   12/179 (6.70%) 
Blood and lymphatic system disorders     
Anaemia  1  1/180 (0.56%)  0/179 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/180 (0.00%)  1/179 (0.56%) 
Bradycardia  1  1/180 (0.56%)  0/179 (0.00%) 
Cardiac failure congestive  1  0/180 (0.00%)  2/179 (1.12%) 
Myocardial infarction  1  0/180 (0.00%)  1/179 (0.56%) 
Sinus bradycardia  1  1/180 (0.56%)  0/179 (0.00%) 
Eye disorders     
Vision blurred  1  1/180 (0.56%)  0/179 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/180 (0.56%)  1/179 (0.56%) 
Duodenal ulcer perforation  1  1/180 (0.56%)  0/179 (0.00%) 
Pancreatitis acute  1  0/180 (0.00%)  1/179 (0.56%) 
Vomiting  1  0/180 (0.00%)  1/179 (0.56%) 
Infections and infestations     
Abscess  1  0/180 (0.00%)  1/179 (0.56%) 
Bronchitis  1  0/180 (0.00%)  1/179 (0.56%) 
Viral infection  1  0/180 (0.00%)  1/179 (0.56%) 
Injury, poisoning and procedural complications     
Humerus fracture  1  0/180 (0.00%)  1/179 (0.56%) 
Intentional overdose  1  0/180 (0.00%)  1/179 (0.56%) 
Joint dislocation  1  0/180 (0.00%)  1/179 (0.56%) 
Metabolism and nutrition disorders     
Anorexia  1  0/180 (0.00%)  1/179 (0.56%) 
Dehydration  1  0/180 (0.00%)  1/179 (0.56%) 
Hypokalaemia  1  0/180 (0.00%)  1/179 (0.56%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/180 (0.00%)  1/179 (0.56%) 
Chest wall pain  1  0/180 (0.00%)  1/179 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-small cell lung cancer  1  0/180 (0.00%)  1/179 (0.56%) 
Papillary thyroid cancer  1  1/180 (0.56%)  0/179 (0.00%) 
Renal cancer  1  0/180 (0.00%)  1/179 (0.56%) 
Renal cell carcinoma stage unspecified  1  0/180 (0.00%)  1/179 (0.56%) 
Renal neoplasm  1  0/180 (0.00%)  1/179 (0.56%) 
Nervous system disorders     
Cerebrovascular accident  1  1/180 (0.56%)  0/179 (0.00%) 
Dizziness  1  1/180 (0.56%)  0/179 (0.00%) 
Global amnesia  1  0/180 (0.00%)  1/179 (0.56%) 
Hypoaesthesia  1  0/180 (0.00%)  1/179 (0.56%) 
Presyncope  1  1/180 (0.56%)  0/179 (0.00%) 
Syncope  1  0/180 (0.00%)  1/179 (0.56%) 
Psychiatric disorders     
Major depression  1  0/180 (0.00%)  1/179 (0.56%) 
Suicidal ideation  1  0/180 (0.00%)  1/179 (0.56%) 
Reproductive system and breast disorders     
Breast pain  1  0/180 (0.00%)  1/179 (0.56%) 
Ovarian cyst  1  1/180 (0.56%)  0/179 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/180 (0.00%)  2/179 (1.12%) 
Skin and subcutaneous tissue disorders     
Cold sweat  1  1/180 (0.56%)  0/179 (0.00%) 
Dermatitis allergic  1  0/180 (0.00%)  1/179 (0.56%) 
Vascular disorders     
Hypotension  1  1/180 (0.56%)  0/179 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Switch Delayed Switch
Affected / at Risk (%) Affected / at Risk (%)
Total   100/180 (55.56%)   66/179 (36.87%) 
Gastrointestinal disorders     
Constipation  1  10/180 (5.56%)  6/179 (3.35%) 
Diarrhoea  1  29/180 (16.11%)  21/179 (11.73%) 
Nausea  1  31/180 (17.22%)  13/179 (7.26%) 
General disorders     
Fatigue  1  12/180 (6.67%)  6/179 (3.35%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  9/180 (5.00%)  3/179 (1.68%) 
Nervous system disorders     
Dizziness  1  16/180 (8.89%)  13/179 (7.26%) 
Dyskinesia  1  7/180 (3.89%)  12/179 (6.70%) 
Tremor  1  9/180 (5.00%)  6/179 (3.35%) 
Psychiatric disorders     
Depression  1  9/180 (5.00%)  7/179 (3.91%) 
Renal and urinary disorders     
Chromaturia  1  12/180 (6.67%)  10/179 (5.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00219284     History of Changes
Other Study ID Numbers: CELC200AUS11
First Submitted: June 30, 2005
First Posted: September 22, 2005
Results First Submitted: December 7, 2010
Results First Posted: March 15, 2011
Last Update Posted: March 30, 2017