Study:
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
Rationale:
n/a
Purpose:
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
Recruiting:
n/a
| 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.
ClinicalTrials.gov 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