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Last Updated: December 15, 2024

CLINICAL TRIALS PROFILE FOR ENTACAPONE


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505(b)(2) Clinical Trials for Entacapone

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 Entacapone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00044083 ↗ Clinical Trial of Tolcapone for Cognition in Schizophrenia Terminated National Institute of Mental Health (NIMH) Phase 2 2002-08-01 This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain. ...
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.
NCT00192855 ↗ Entacapone Augmentation for Schizophrenia Completed Rambam Health Care Campus N/A 2003-06-01 This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.
NCT00199394 ↗ A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease Completed Kyowa Hakko Kirin UK, Ltd. Phase 3 2004-11-01 The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Entacapone

Condition Name

Condition Name for Entacapone
Intervention Trials
Parkinson's Disease 17
Healthy 7
Parkinson Disease 6
Parkinson's Disease (PD) 2
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Condition MeSH

Condition MeSH for Entacapone
Intervention Trials
Parkinson Disease 27
Schizophrenia 2
Cocaine-Related Disorders 2
Disease 2
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Clinical Trial Locations for Entacapone

Trials by Country

Trials by Country for Entacapone
Location Trials
United States 76
Italy 12
Canada 11
Germany 9
France 6
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Trials by US State

Trials by US State for Entacapone
Location Trials
New York 6
Florida 5
California 5
Arizona 4
Maryland 4
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Clinical Trial Progress for Entacapone

Clinical Trial Phase

Clinical Trial Phase for Entacapone
Clinical Trial Phase Trials
Phase 4 8
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Entacapone
Clinical Trial Phase Trials
Completed 32
Terminated 4
Unknown status 3
[disabled in preview] 3
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Clinical Trial Sponsors for Entacapone

Sponsor Name

Sponsor Name for Entacapone
Sponsor Trials
Novartis 9
Bial - Portela C S.A. 6
Orion Corporation, Orion Pharma 5
[disabled in preview] 7
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Sponsor Type

Sponsor Type for Entacapone
Sponsor Trials
Industry 32
Other 19
NIH 4
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