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Last Updated: October 21, 2020

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CLINICAL TRIALS PROFILE FOR STALEVO 125

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505(b)(2) Clinical Trials for Stalevo 125

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Stalevo 125

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.).
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Stalevo 125

Condition Name

Condition Name for Stalevo 125
Intervention Trials
Parkinson's Disease 11
Parkinson Disease 2
Idiopathic Parkinson's Disease 1
Sleep Disorders 1
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Condition MeSH

Condition MeSH for Stalevo 125
Intervention Trials
Parkinson Disease 15
Sleep Wake Disorders 1
Parasomnias 1
Narcolepsy 1
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Clinical Trial Locations for Stalevo 125

Trials by Country

Trials by Country for Stalevo 125
Location Trials
United States 37
Italy 11
Canada 11
Finland 7
United Kingdom 7
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Trials by US State

Trials by US State for Stalevo 125
Location Trials
Michigan 3
California 3
Florida 3
Virginia 2
Ohio 2
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Clinical Trial Progress for Stalevo 125

Clinical Trial Phase

Clinical Trial Phase for Stalevo 125
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Stalevo 125
Clinical Trial Phase Trials
Completed 12
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for Stalevo 125

Sponsor Name

Sponsor Name for Stalevo 125
Sponsor Trials
Orion Corporation, Orion Pharma 10
Novartis Pharmaceuticals 2
IMPAX Laboratories, Inc. 1
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Sponsor Type

Sponsor Type for Stalevo 125
Sponsor Trials
Industry 14
Other 4
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