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A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson`s Disease


A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson`s Disease (PD) and Cognitive Impairment




The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson`s disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still being tested for safety and effectiveness. Approximately one hundred (100) patients will participate in this research trial. The research trial will be conducted in approximately thirty (30) medical centers in the following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The research trial will last until June 2012.

Study Status: Completed


Condition Intervention Phase
Parkinson`s Disease With Cognitive Impairments Drug: safinamide
Drug: placebo
Phase 2

Verified by Newron Pharmaceuticals S.p.A. June, 2012

Sponsored by: Newron Pharmaceuticals S.p.A.
Information provided by: Newron Pharmaceuticals S.p.A. identifier: NCT01211587

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio
United States

Jonathan Willmer, MD, FRCPC., Study Director

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