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Entacapone

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment285
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 StatesPHASE2 COMPLETED 285Feb 1, 2003Jul 1, 2007Jan 11, 20241 United States
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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 — 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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