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

A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00058838

Enrollment

854

Registered

2003-04-15

Start date

2003-04-30

Completion date

2004-09-30

Last updated

2006-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

Interventions

DRUGsumanirole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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 visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo	—

Countries

Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Mexico, Peru, Puerto Rico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026