18 completed, 4 terminated, 1 recruiting, 1 withdrawn. 10 Phase 3, 6 Phase 1, 5 Phase 2, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 6, Terminated 2, Recruiting 1, Withdrawn 1 |
| Phase 1 | 6 | Completed 6 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 4 | 3 | Completed 2, Terminated 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 |
| A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers Safinamide 50 mg, Safinamide 100mg - Healthy | Phase 1 | Completed | Zambon SpA | 24 | 2021-06-21 | 2023-03-17 |
| Safinamide for Multiple System Atrophy (MSA) Safinamide Methanesulfonate, Safinamide Methanesulfonate matching placebo - Multiple System Atrophy | Phase 2 | Completed | Zambon SpA | 49 | 2019-10-29 | 2021-10-13 |
| 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100mg, Safinamide Methanesulfonate matching placebo - Dyskinesia, Drug-Induced, Parkinson Disease | Phase 3 | Withdrawn | Zambon SpA | 2019-10-01 | 2020-06-17 | |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 |
| Effect of Safinamide on Parkinson's Disease Related Chronic Pain Safinamide Methanesulfonate, Safinamide methanesulfonate matching placebo - Idiopathic Parkinson Disease | Phase 4 | Completed | Zambon SpA | 94 | 2019-04-09 | 2023-05-22 |
| Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease Safinamide - Idiopathic Parkinson's Disease (at Later Stage) | Phase 4 | Terminated | Alain Kaelin | 11 | 2019-02-18 | 2026-03-13 |
| Overnight Switch From Rasagiline To Safinamide Safinamide - Parkinson Disease | Phase 4 | Completed | IRCCS San Raffaele Roma | 20 | 2018-05-01 | 2024-04-10 |
| Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) XADAGO (safinamide) - Idiopathic Parkinson Disease | Completed | Supernus Pharmaceuticals, Inc. | 164 | 2017-11-30 | 2023-06-07 | |
| Safinamide Steady State Interaction With Rosuvastatin 100 mg safinamide, 20 mg rosuvastatin calcium period 1, 20 mg rosuvastatin calcium period 2 - Healthy | Phase 1 | Completed | Cross Research S.A. | 24 | 2017-05-22 | 2017-08-01 |
| Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers Diclofenac sodium, Diclofenac sodium and safinamide - Healthy | Phase 1 | Completed | Zambon SpA | 24 | 2015-05-01 | 2016-04-15 |
| Safinamide Renal Impairment Trial 50mg safinamide - Renal Impairment | Phase 1 | Completed | Newron Pharmaceuticals SPA | 24 | 2011-06-01 | 2013-03-29 |
| A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging Safinamide - Parkinson Disease | Phase 2 | Terminated | Newron Pharmaceuticals SPA | 5 | 2011-03-01 | 2017-09-18 |
| A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease safinamide, placebo - Parkinson's Disease With Cognitive Impairments | Phase 2 | Completed | Newron Pharmaceuticals SPA | 103 | 2010-09-01 | 2013-03-29 |
| Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects Placebo, Safinamide - Parkinson's Disease | Phase 2 | Completed | Newron Pharmaceuticals SPA | 26 | 2010-04-01 | 2013-03-29 |
| 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 |
| A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics Safinamide + Levodopa, Placebo + Levodopa - Idiopathic Parkinson's Disease | Phase 1 / Phase 2 | Completed | Newron Pharmaceuticals SPA | 24 | 2009-09-01 | 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 |
| A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics safinamide - Hepatic Impairment | Phase 1 | Completed | Newron Pharmaceuticals SPA | 24 | 2009-04-01 | 2013-03-29 |
| 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 |
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Parkinson Disease (18) · Agnosia (1) · Dyskinesia, Drug-Induced (1) · Dyskinesias (1) · Liver Diseases (1) · Lymphoma, Follicular (1) · Multiple System Atrophy (1) · Pain (1) · Renal Insufficiency (1) · Thyroid Dyshormonogenesis 2A (1)
Newron Pharmaceuticals SPA (13) · Zambon SpA (6) · Alain Kaelin (1) · Cross Research S.A. (1) · IRCCS San Raffaele Roma (1) · Supernus Pharmaceuticals, Inc. (1) · Universita di Verona (1)
Italy (6) · Germany (5) · Spain (4) · Switzerland (4) · United States (4) · Austria (2) · Canada (2) · China (2) · France (2) · South Africa (2) · Argentina (1) · Brazil (1) · Bulgaria (1) · Chile (1) · Colombia (1)
Jonathan Willmer, MD (4) · Charlotte Keywood, MD (3) · Fabrizio Stocchi, MD (2) · Madhuri Behari, MD (2) · Marco Onofri, MD (2) · Milko Radicioni, 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) · Anne Marquet, PharmaD, PhD (1)
PMID 36346534, PMID 38070039, PMID 38565814
2017 (1), 2018 (1), 2025 (1)