A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
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.
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.
San Luis Obiapo, California 93401, United States
Glenbrook, Illinois 60025, United States
Buenos Aires, Buenos Aires 1117, Argentina
Buenos Aires, Buenos Aires 1221, Argentina
Buenos Aires, Buenos Aires 1419, Argentina