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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00219284

First received: June 30, 2005

Last updated: February 16, 2011

Last verified: February 2011

History of Changes

Results First Received: December 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Parkinson's Disease With End of Dose "Wearing Off"
Intervention:	Drug: Carbidopa/levodopa/entacapone

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

Immediate 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 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.

Delayed 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.

Participant Flow for 2 periods

Period 1: Treatment Phase - 16 Weeks

	Immediate Switch	Delayed Switch
STARTED	180	179
COMPLETED	136	128
NOT COMPLETED	44	51
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 2: Extension Phase - 8 Weeks

	Immediate Switch	Delayed Switch
STARTED	114 ^[1]	106 ^[1]
COMPLETED	112	99
NOT COMPLETED	2	7
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.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Immediate 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 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.
Delayed 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	Total of all reporting groups

Baseline Measures

	Immediate Switch	Delayed Switch	Total
Number of Participants [units: participants]	180	179	359
Age [units: years] Mean ± Standard Deviation	68.7 ± 9.18	68.3 ± 10.38	68.5 ± 9.78
Gender [units: participants]
Female	74	71	145
Male	106	108	214

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Show Outcome Measure 1

2. Secondary:

Change in Parkinson’s Disease Quality of Life Score From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Show Outcome Measure 2

3. Secondary:

Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

Show Outcome Measure 3

4. Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

Show Outcome Measure 4

5. Secondary:

Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Show Outcome Measure 5

6. Secondary:

Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

Hide Outcome Measure 6

Measure Type	Secondary
Measure Title	Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

Description

Immediate Switch

Delayed 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.

Measured Values

	Immediate Switch	Delayed Switch
Number of Participants Analyzed [units: participants]	150	155
Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8 [units: Units on a scale] Least Squares Mean ± Standard Error	-5.8 ± 1.48	-1.9 ± 1.31

No statistical analysis provided for Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8

7. Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment [ Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group) ]

Show Outcome Measure 7

8. Secondary:

Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment [ Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group) ]

Show Outcome Measure 8

9. Secondary:

Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment [ Time Frame: Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group) ]

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00219284 History of Changes
Other Study ID Numbers:	CELC200AUS11
Study First Received:	June 30, 2005
Results First Received:	December 7, 2010
Last Updated:	February 16, 2011
Health Authority:	United States: Food and Drug Administration

To Top