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Last Updated: January 20, 2020

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CLINICAL TRIALS PROFILE FOR STALEVO 100

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505(b)(2) Clinical Trials for Stalevo 100

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 100

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

Clinical Trial Conditions for Stalevo 100

Condition Name

Condition Name for Stalevo 100
Intervention Trials
Parkinson's Disease 11
Parkinson Disease 2
Pharmacokinetics 1
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Condition MeSH

Condition MeSH for Stalevo 100
Intervention Trials
Parkinson Disease 15
Sleep Wake Disorders 1
Parasomnias 1
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Clinical Trial Locations for Stalevo 100

Trials by Country

Trials by Country for Stalevo 100
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 100
Location Trials
California 3
Florida 3
Michigan 3
Arizona 2
Virginia 2
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Clinical Trial Progress for Stalevo 100

Clinical Trial Phase

Clinical Trial Phase for Stalevo 100
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 100
Clinical Trial Phase Trials
Completed 12
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Stalevo 100

Sponsor Name

Sponsor Name for Stalevo 100
Sponsor Trials
Orion Corporation, Orion Pharma 10
Novartis Pharmaceuticals 2
IRCCS San Raffaele 1
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Sponsor Type

Sponsor Type for Stalevo 100
Sponsor Trials
Industry 14
Other 4
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