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sumanirole

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,454

FDA Designations

No designations recorded

Clinical trial landscape

sumanirole · 2 trials · 1 indication

Phase 3 2
NCT00058838Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's DiseaseParkinson Disease
COMPLETED854 Analytics
NCT00036218Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.Parkinson Disease
COMPLETED600 Analytics
PHASE3COMPLETED
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
Parkinson DiseaseUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
Parkinson DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about sumanirole

What is sumanirole used for?

Sumanirole is an investigational small molecule being developed for the treatment of the signs and symptoms of early Parkinson's disease. It is being studied in patients aged 30 years and older. The drug is not approved and remains in clinical development.

Who makes sumanirole?

Sumanirole is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical trials for Parkinson's disease.

What phase is sumanirole in?

Sumanirole is in Phase 3 clinical development for early Parkinson's disease. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, but the drug is not yet available commercially.

What clinical trials is sumanirole in?

Sumanirole has been studied in two completed Phase 3 trials: NCT00036218 with 600 participants and NCT00058838 with 854 participants, both evaluating the drug for early Parkinson's disease. These trials were conducted in multiple countries including the United States, Argentina, Mexico, and several European nations.

Is sumanirole the same as other Parkinson's drugs?

Sumanirole is a distinct investigational compound developed by Pfizer. It is not known to be the same as any other marketed drug. Its mechanism of action has not been disclosed in available clinical trial information.