CLINICAL TRIALS PROFILE FOR STALEVO 50

505(b)(2) Clinical Trials for STALEVO 50

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 STALEVO 50

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.
NCT00125567 ↗	Stalevo in Early Wearing-Off Patients	Completed	Orion Corporation, Orion Pharma	Phase 4	2005-08-01	The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
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.).

Clinical Trial Conditions for STALEVO 50

Condition Name

Condition Name for STALEVO 50
Intervention	Trials
Parkinson's Disease	11
Parkinson Disease	3
Idiopathic Parkinson's Disease	1
Parkinson´s Disease	1

Condition MeSH

Condition MeSH for STALEVO 50
Intervention	Trials
Parkinson Disease	16
Sleep Wake Disorders	1
Parasomnias	1
Narcolepsy	1

Clinical Trial Locations for STALEVO 50

Trials by Country

Trials by Country for STALEVO 50
Location	Trials
United States	37
Canada	11
Italy	11
Finland	8
United Kingdom	7

Trials by US State

Trials by US State for STALEVO 50
Location	Trials
Michigan	3
Florida	3
California	3
Pennsylvania	2
New York	2

Clinical Trial Progress for STALEVO 50

Clinical Trial Phase

Clinical Trial Phase for STALEVO 50
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	6

Clinical Trial Status

Clinical Trial Status for STALEVO 50
Clinical Trial Phase	Trials
Completed	13
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for STALEVO 50

Sponsor Name

Sponsor Name for STALEVO 50
Sponsor	Trials
Orion Corporation, Orion Pharma	10
Novartis Pharmaceuticals	2
IMPAX Laboratories, Inc.	1

Sponsor Type

Sponsor Type for STALEVO 50
Sponsor	Trials
Industry	16
Other	4