Safinamide

Generic Name
Safinamide
Brand Names
Xadago
Drug Type
Small Molecule
Chemical Formula
C17H19FN2O2
CAS Number
133865-89-1
Unique Ingredient Identifier
90ENL74SIG
Background

Safinamide is for the treatment of parkinson's disease. It was approved in Europe in February 2015, and in the United States on March 21, 2017.

Indication

用于治疗帕金森病

Associated Conditions
Parkinson's Disease (PD)
Associated Therapies
-

Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

First Posted Date
2019-05-30
Last Posted Date
2024-03-15
Lead Sponsor
Alain Kaelin
Target Recruit Count
23
Registration Number
NCT03968744
Locations
🇨🇭

Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC), Lugano, Switzerland

A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-03-19
Last Posted Date
2024-03-20
Lead Sponsor
Zambon SpA
Target Recruit Count
307
Registration Number
NCT03881371
Locations
🇨🇳

Beijing Tiantan Hospital Affiliated to Capital Medical University 首都医科大学附属北京天坛医院, Beijing, No. 6, Tiantan XI Li, Chongwen District, China

🇨🇳

The First Bethune Hospital of Jilin University, Changchun, No. 71, Xin Min Street, China

🇨🇳

The Second Affiliated Hospital of Zhejiang University 浙江大学医学院附属第二医院, Hangzhou, No. 88, Jie Fang Rd., China

and more 28 locations

Overnight Switch From Rasagiline To Safinamide

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-02-18
Last Posted Date
2024-04-10
Lead Sponsor
IRCCS San Raffaele Roma
Target Recruit Count
20
Registration Number
NCT03843944
Locations
🇮🇹

IRCCS San Raffaele, Roma, Italy

18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-01-31
Last Posted Date
2011-01-31
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
544
Registration Number
NCT01286935

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

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-12-22
Last Posted Date
2017-09-18
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
5
Registration Number
NCT01264861
Locations
🇺🇸

Molecular Neuroimaging, LLC, New Haven, Connecticut, United States

A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease

First Posted Date
2010-09-29
Last Posted Date
2013-03-29
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
103
Registration Number
NCT01211587
Locations
🇪🇸

Hosptial General Univ Gregorio Maranon, Madrid, Spain

🇺🇸

The Parkinson's Institute, Sunnyvale, California, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

and more 12 locations

Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-08-24
Last Posted Date
2010-08-24
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
669
Registration Number
NCT01187966

Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-04-29
Last Posted Date
2013-03-29
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
26
Registration Number
NCT01113320
Locations
🇦🇹

Medical University Innsbruck, Dept. of Neurology, Innsbruck, Austria

🇫🇷

Hôpital Roger Sallengro, Lille, France

🇦🇹

Medical University Graz, Klinische Abteilung für Spezielle Neurologie, Graz, Austria

and more 8 locations

A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-12-07
Last Posted Date
2013-03-29
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
24
Registration Number
NCT01027169
Locations
🇩🇪

CRS Clinical Research Services Kiel GmbH, Kiel, Germany

Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2009-03-19
Last Posted Date
2017-09-18
Lead Sponsor
Newron Pharmaceuticals SPA
Target Recruit Count
964
Registration Number
NCT00865579
Locations
🇷🇴

Research Site, Timis, Romania

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