Overview

A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging

Status:
Terminated
Trial end date:
2012-01-24
Target enrollment:
Participant gender:
Summary
This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized that safinamide acts by increasing the available dopamine in those areas of the brain where dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the brain is involved in controlling body movements. Safinamide has been extensively studied in animals, and has been shown to increase the level of dopamine in these animals. Safinamide has also been tested in patients with Parkinson disease. The goal of this research trial is to see if safinamide is safe and well tolerated and to better understand how it affects the dopamine system in the brain in individuals with Parkinson disease. Data from this trial may provide essential information about the effectiveness and safety of these doses of safinamide in patients with early Parkinson disease, who are already receiving a stable dose of their normal Parkinson disease treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Newron
Newron Pharmaceuticals SPA
Treatments:
Dopamine
Dopamine Agents
Serotonin