NCT01264861

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

Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Safinamide	Safinamide 100 mg/day = two 50 mg tablets administered orally, once a day, in the morning, with or without food. Safinamide 200 mg/day = four 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 150 mg = three 50 mg tablets administered orally, once a day, in the morning, with or without food. Safinamide 300 mg/day = six 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 250 mg = five 50 mg tablets administered orally, once a day, in the morning, with or without food.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-24
• First posted: 2010-12-22
• Last updated: 2017-09-18

Locations

1 site across 1 country: United States