Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 5:47 PM
Study NCT ID:
NCT01264861
Status:
TERMINATED
Last Update Posted:
2017-09-18
First Post:
2010-12-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging
Sponsor:
Newron Pharmaceuticals SPA
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Dopamine transporter brain imaging trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: