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sumanirole

Phase 3

Parkinson Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jun 7, 2006

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,454
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00058838Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's DiseasePHASE3 COMPLETED 854Apr 1, 2003Sep 1, 2004Jun 7, 2006134 United States, Argentina +12
NCT00036218Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.PHASE3 COMPLETED 600Dec 1, 2001Apr 1, 2003Jun 7, 2006102 United States, Argentina +2
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Study Endpoints
Primary Endpoints
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
Secondary Endpoints
To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo
To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
sumaniroleDRUG -
ropiniroleDRUG -
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites134

Inclusion Criteria: Idiopathic Parkinson's disease \< 7 years duration Modified Hoehn and Yahr Scale Stages I through III Age greater than or equal to 30 years old Patients or their partners must use adequate contraceptive methods Patients who are willing and able to comply with scheduled visit...

Countries:United StatesArgentinaAustraliaAustriaBelgiumColombiaFranceGermanyGreeceItalyMexicoPeruPuerto RicoSpain
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