Recent Updates
Recently added Catalysts

sumanirole

Phase 3

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

sumanirole development status

Highest phase Phase 3
Registered trials 3 across 1 sponsor since May 2002

sumanirole target and mechanism

Molecular targetDRD2
Target classAgonist
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,454

FDA Designations

No designations recorded

sumanirole clinical trials

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
sumaniroleDRUG -
ropiniroleDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about sumanirole

What is sumanirole?

Sumanirole is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for the treatment of Parkinson disease. It was studied in Phase 3 clinical trials for the signs and symptoms of early Parkinson disease. Sumanirole has not been approved and remains an investigational therapy in clinical development.

What is sumanirole used for in Parkinson disease?

Sumanirole was developed to treat the signs and symptoms of early Parkinson disease. Two Phase 3 studies evaluated it in adults aged 30 years and older with early Parkinson disease, enrolling a combined 1,454 participants. Sumanirole is investigational and is not an approved treatment for Parkinson disease.

What does sumanirole target?

Sumanirole targets DRD2, the dopamine D2 receptor, and acts as an agonist at that receptor. This DRD2 agonist activity is the basis for its development in Parkinson disease, where dopamine signaling is impaired. Sumanirole is a small molecule and remains an investigational agent.

Who makes sumanirole?

Sumanirole is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 3 clinical program evaluating sumanirole in early Parkinson disease. The drug remains investigational and has not been approved for any indication.

What phase is sumanirole in?

Sumanirole reached Phase 3 clinical development for Parkinson disease. Both Phase 3 trials have been completed, and no trials are currently active. Sumanirole is investigational and is not FDA approved; it has not completed regulatory review for marketing authorization.

What clinical trials is sumanirole in?

Sumanirole was studied in two completed Phase 3 trials: NCT00058838, which enrolled 854 participants across the United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Mexico, Peru, Puerto Rico, and Spain, and NCT00036218, which enrolled 600 participants in the United States, Argentina, Mexico, and Puerto Rico. Both evaluated early Parkinson disease.