Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

This study has been completed.

Study NCT00391898 Information provided by Novartis

First Received on October 24, 2006. Last Updated on February 16, 2011 History of Changes

Results First Received: January 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Parkinson's Disease
Interventions:	Drug: Levodopa/carbidopa/entacapone Drug: Levodopa/carbidopa

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Levodopa/Carbidopa/Entacapone	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
Levodopa/Carbidopa	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Participant Flow: Overall Study

	Levodopa/Carbidopa/Entacapone	Levodopa/Carbidopa
STARTED	46 ^[1]	49
COMPLETED	35	39
NOT COMPLETED	11	10
Adverse Event	3	0
Other	8	10

[1]	Safety population for Levodopa/carbidopa/entacapone is 45, for Levodopa/carbidopa, per randomized.

Baseline Characteristics

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Reporting Groups

	Description
Levodopa/Carbidopa/Entacapone	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
Levodopa/Carbidopa	Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Baseline Measures

	Levodopa/Carbidopa/Entacapone	Levodopa/Carbidopa	Total
Number of Participants [units: participants]	45	49	94
Age [units: Years] Mean ± Standard Deviation	66.40 ± 8.18	66.45 ± 9.04	66.43 ± 8.59
Gender ^[1] [units: participants]
Female	25	22	47
Male	20	27	47
Region of Enrollment ^[2] [units: participants]
Spain	45	49	94

[1]	Baseline Measure based on Safety population
[2]	Baseline measure based on safety population.

Outcome Measures

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1. Primary:

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) ]

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2. Secondary:

Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3 [ Time Frame: Baseline to end of study (Month 3) ]

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3. Secondary:

Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3 [ Time Frame: Baseline to end of study (Month 3) ]

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4. Secondary:

Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3 [ Time Frame: Baseline to end of study (Month 3) ]

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5. Secondary:

Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3 [ Time Frame: Baseline to end of study (Month 3) ]

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6. Secondary:

Patient and Investigator Global Evaluation of the Patient [ Time Frame: Baseline to end of study (Month 3) ]

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7. Secondary:

Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3 [ Time Frame: Baseline to end of study (Month 3) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 (i.e., 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00391898 History of Changes
Other Study ID Numbers:	CELC200AES03
Study First Received:	October 24, 2006
Results First Received:	January 4, 2011
Last Updated:	February 16, 2011
Health Authority:	Spain: Agencia Española del Medicamento y Productos Sanitarios. Ministerio de Sanidad y Consumo