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Last Updated: September 24, 2021

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

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

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
Autonomic Nervous System Diseases 1
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Condition MeSH

Condition MeSH for Carbidopa; Entacapone; Levodopa
Intervention Trials
Parkinson Disease 16
Cocaine-Related Disorders 2
Atrophy 1
Shy-Drager Syndrome 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
Italy 11
Canada 11
Germany 6
Turkey 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
[disabled in preview] 6
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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
Novartis Pharmaceuticals 3
Orion Corporation, Orion Pharma 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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