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Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Parkinson Disease

Treatments

Drug: ropinirole
Drug: sumanirole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00036218
666E-CNS-0075-021

Details and patient eligibility

About

The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

102

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Data sourced from clinicaltrials.gov

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