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Entacapone

Phase 4

Parkinson's Disease | Small molecule | Neurology |Novartis AG|Trials Updated: Jan 11, 2024

Entacapone development status

Highest phase Phase 4 (NCT00143026)
Phase scored for NVSPhase 2
Registered trials 2 across 1 sponsor since Sep 2005

Entacapone target and mechanism

Molecular targetCOMT
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL953

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment285

FDA Designations

No designations recorded

Entacapone clinical trials

Entacapone · 1 trial · 1 indication

Phase 2 1
NCT00237263An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United StatesParkinson's Disease
COMPLETED285 Analytics
PHASE2COMPLETED
An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events during the long term treatment (maximum 3 years)
Blood pressure at every 12 weeks
Laboratory test at every 16 weeks
ECG at every 16 weeks

Secondary Endpoints

On time based on patient diary (up to 104 weeks)
UPDRS score at every 16 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
EntacaponeDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Attended the Phase IIb study * Able to fill out the patient diary Exclusion Criteria: * Serious heart, pulmonary, renal, hepatic or gastrointestinal disease * Dementia symptoms * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may a...

Countries:United States
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Frequently asked questions about Entacapone

What is Entacapone used for in Parkinson's Disease?

Entacapone is an investigational small molecule being studied in Parkinson's Disease, specifically for patients experiencing end-of-dose wearing-off. It is being developed by Novartis AG and is currently in Phase 2 clinical development. Wearing-off refers to the return of Parkinson's symptoms between doses of levodopa therapy.

What does Entacapone target?

Entacapone targets COMT, which stands for catechol-O-methyltransferase. It is classified as a COMT inhibitor. By targeting this enzyme, the drug is designed to affect the metabolism of dopamine-related compounds in the body. This mechanism is relevant to its study in Parkinson's Disease patients with end-of-dose wearing-off.

Who makes Entacapone?

Entacapone is being developed by Novartis AG, which trades under the ticker NVS. The company is the sponsor associated with the clinical development of this COMT inhibitor for Parkinson's Disease. Novartis AG is a multinational pharmaceutical company headquartered in Switzerland.

What phase is Entacapone in?

Entacapone is in Phase 2 clinical development for Parkinson's Disease. It is an investigational small molecule and is not described as approved. The Phase 2 program includes one completed trial evaluating the drug in patients with Parkinson's Disease who experience end-of-dose wearing-off.

What clinical trials is Entacapone in?

Entacapone has been studied in the Phase 2 trial NCT00237263, titled an extension study of Entacapone in patients with Parkinson's Disease with end-of-dose wearing-off. The trial is completed and enrolled 285 participants. It was conducted in the United States and included patients aged 20 years and older of all sexes.

Is Entacapone a COMT inhibitor?

Yes, Entacapone is classified as a COMT inhibitor. Its molecular target is COMT, or catechol-O-methyltransferase. This target class places it among compounds designed to inhibit that enzyme. It is being studied as a small molecule in Phase 2 development for Parkinson's Disease, specifically for patients with end-of-dose wearing-off.