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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: sumanirole

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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