6 completed, 2 terminated, 1 recruiting, 1 withdrawn. 10 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 6, Terminated 2, Recruiting 1, Withdrawn 1 |
Follow safinamide: new trials by email Literature Review of safinamide trials Research Report on safinamide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safinamide vs Placebo for Pain in Patients With Parkinson's Disease and Motor Fluctuations Safinamide, Placebo - PARKINSON DISEASE (Disorder), Pain | Phase 3 | Recruiting | Universita di Verona | 60 | 2026-04-28 | 2026-08-13 |
| Safinamide for Levodopa-induced Dyskinesia (PD-LID) Safinamide Methanesulfonate 150mg, Safinamide Methanesulfonate 100mg, Safinamide Methanesulfonate matching placebo - Dyskinesia, Drug-Induced, Parkinson Disease | Phase 3 | Withdrawn | Zambon SpA | 2019-10-01 | 2020-06-17 | |
| 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 Safinamide, Placebo - Parkinson Disease | Phase 3 | Completed | Zambon SpA | 307 | 2019-08-01 | 2024-03-20 |
| MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) Safinamide, MAO-B inhibitor, Placebo - Idiopathic Parkinson's Disease | Phase 3 | Terminated | Newron Pharmaceuticals SPA | 507 | 2009-10-01 | 2013-03-29 |
| Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients Safinamide - Parkinson's Disease | Phase 3 | Terminated | Newron Pharmaceuticals SPA | 964 | 2009-04-01 | 2017-09-18 |
| MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Safinamide (as add-on therapy) - Idiopathic Parkinson's Disease | Phase 3 | Completed | Newron Pharmaceuticals SPA | 679 | 2007-11-01 | 2013-10-29 |
| 18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD Safinamide, Placebo - Parkinson's Disease | Phase 3 | Completed | Newron Pharmaceuticals SPA | 544 | 2007-08-01 | 2011-01-31 |
| Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease Safinamide, Placebo - Parkinson's Disease | Phase 3 | Completed | Newron Pharmaceuticals SPA | 669 | 2007-01-01 | 2010-08-24 |
| Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension) Safinamide, Placebo - Parkinson's Disease | Phase 3 | Completed | Newron Pharmaceuticals SPA | 227 | 2005-06-01 | 2008-03-25 |
| Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist Safinamide, Placebo - Idiopathic Parkinson's Disease | Phase 3 | Completed | Newron Pharmaceuticals SPA | 269 | 2004-12-01 | 2008-03-25 |
Parkinson Disease (10) · Agnosia (1) · Dyskinesia, Drug-Induced (1) · Dyskinesias (1) · Pain (1)
Newron Pharmaceuticals SPA (7) · Zambon SpA (2) · Universita di Verona (1)
Italy (2) · Argentina (1) · Brazil (1) · Bulgaria (1) · Canada (1) · Chile (1) · China (1) · Colombia (1) · Croatia (1) · Czechia (1) · Finland (1) · Germany (1) · India (1) · Mexico (1) · Peru (1)
Jonathan Willmer, MD (3) · Fabrizio Stocchi, MD (2) · Madhuri Behari, MD (2) · Marco Onofri, MD (2) · Mohit Bhatt, MD (2) · Rupam Borgohain, MD (2) · Ajit Kumar Roy, MD (1) · Ajit Roy, MD (1) · Ajit Sowani, MD (1) · Alessandra Monge, MD (1) · Ana Campeanu, MD (1) · Angelo Bulboaca, MD (1) · Antonio Vacquez, MD (1) · Arun B Shah, MD (1) · Arunkumar Shah, MD (1)
PMID 36346534, PMID 38070039, PMID 38565814
2025 (1)