drugset / Trial / NCT01264861

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

NCT01264861

Phase 2 Terminated 5 enrolled Newron Pharmaceuticals SPA
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2011-03
Primary completion
2012-01
Completion
2012-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Safinamide Small molecule 100 mg Oral
Subject Safinamide Small molecule 200 mg Oral
Subject Safinamide Small molecule 300 mg Oral

Indications