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CLINICAL TRIALS PROFILE FOR CARBIDOPA; ENTACAPONE; LEVODOPA

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505(b)(2) Clinical Trials for Carbidopa; Entacapone; Levodopa

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01766258	Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations	Completed	Orion Corporation, Orion Pharma	Phase 2	2011-05-01	The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.

All Clinical Trials for Carbidopa; Entacapone; Levodopa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00099268	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Completed	Orion Corporation, Orion Pharma	Phase 3	2004-09-01	The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00099268	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Completed	Novartis Pharmaceuticals	Phase 3	2004-09-01	The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.
NCT00134966	A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa	Completed	Novartis	Phase 3	2005-08-01	The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
NCT00143026	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States	Completed	Novartis	Phase 4	2005-07-01	This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
NCT00200447	An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)	Completed	Molecular NeuroImaging	Phase 2	2004-03-01	This study conducted to more fully evaluate the way that carbidopa/levodopa and entacapone may work in the brain. This research study uses [123I]-IBZM and dynamic SPECT imaging to determine the amount and the duration of dopamine release from specific regions in the brain after treatment with either the combination of carbidopa/levodopa or the combination of carbidopa/levodopa/entacapone.
NCT00219284	Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease	Completed	Novartis Pharmaceuticals	Phase 4	2005-01-01	To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.
NCT00391898	Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off	Completed	Novartis	Phase 4	2006-10-01	The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa

Clinical Trial Conditions for Carbidopa; Entacapone; Levodopa

Condition Name

Condition Name for Carbidopa; Entacapone; Levodopa
Intervention	Trials
Parkinson's Disease	11
Healthy	4
Parkinson Disease	3
Multiple System Atrophy	1

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Condition MeSH

Condition MeSH for Carbidopa; Entacapone; Levodopa
Intervention	Trials
Parkinson Disease	16
Cocaine-Related Disorders	2
Shy-Drager Syndrome	1
Primary Dysautonomias	1

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Clinical Trial Locations for Carbidopa; Entacapone; Levodopa

Trials by Country

Trials by Country for Carbidopa; Entacapone; Levodopa
Location	Trials
United States	72
Canada	11
Italy	11
Germany	6
Sweden	3

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Trials by US State

Trials by US State for Carbidopa; Entacapone; Levodopa
Location	Trials
New York	6
Florida	5
California	5
Arizona	4
Texas	4

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Clinical Trial Progress for Carbidopa; Entacapone; Levodopa

Clinical Trial Phase

Clinical Trial Phase for Carbidopa; Entacapone; Levodopa
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2/Phase 3	1

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Clinical Trial Status

Clinical Trial Status for Carbidopa; Entacapone; Levodopa
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	1

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Clinical Trial Sponsors for Carbidopa; Entacapone; Levodopa

Sponsor Name

Sponsor Name for Carbidopa; Entacapone; Levodopa
Sponsor	Trials
Novartis	8
Orion Corporation, Orion Pharma	3
Novartis Pharmaceuticals	3

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Sponsor Type

Sponsor Type for Carbidopa; Entacapone; Levodopa
Sponsor	Trials
Industry	18
Other	7
NIH	2

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