Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

This study has been terminated.

( slow enrollment )

Study NCT00642356 Information provided by Novartis

First Received on March 19, 2008. Last Updated on February 16, 2011 History of Changes

Results First Received: December 14, 2010

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

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
Carbidopa/Levodopa/Entacapone	Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Immediate Release Carbidopa/Levodopa	Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Participant Flow: Overall Study

	Carbidopa/Levodopa/Entacapone	Immediate Release Carbidopa/Levodopa
STARTED	7	7
COMPLETED	5	4
NOT COMPLETED	2	3
Adverse Event	1	0
Protocol Violation	0	3
Lack of Efficacy	1	0

Baseline Characteristics

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Reporting Groups

	Description
Carbidopa/Levodopa/Entacapone	Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Immediate Release Carbidopa/Levodopa	Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Baseline Measures

	Carbidopa/Levodopa/Entacapone	Immediate Release Carbidopa/Levodopa	Total
Number of Participants [units: participants]	7	7	14
Age, Customized [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	1	0	1
>= 65 years	6	7	13
Gender [units: Participants]
Female	5	2	7
Male	2	5	7

Outcome Measures

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1. Primary:

Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9) [ Time Frame: Baseline to 15 minutes prior to 2nd dose at Week 8 ]

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2. Secondary:

Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9) [ Time Frame: Baseline to 15 minutes prior to 2nd dose at Week 8 ]

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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
ClinicalTrials.gov Identifier:	NCT00642356 History of Changes
Other Study ID Numbers:	CELC200AUS14
Study First Received:	March 19, 2008
Results First Received:	December 14, 2010
Last Updated:	February 16, 2011
Health Authority:	United States: Food and Drug Administration