25 completed, 3 terminated, 1 active not recruiting, 1 unknown. 10 Phase 1, 9 Phase 3, 4 Phase 2, 3 Not applicable, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 9, Active not recruiting 1 |
| Phase 3 | 9 | Completed 6, Terminated 2, Withdrawn 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Not applicable | 3 | Completed 2, Unknown 1 |
| Phase 4 | 3 | Completed 3 |
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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 |
|---|---|---|---|---|---|---|
| A Retrospective Chart Review Study of Patients With CLAD-BOS Post Lung Transplantation Bronchiolitis Obliterans Syndrome | Completed | Zambon SpA | 284 | 2024-06-27 | 2026-09-01 | |
| 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 |
| Riluzole Orodispersible Film Replicate Bioavailability Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets - Healthy Participants | Phase 1 | Completed | Cross Research S.A. | 54 | 2021-01-15 | 2025-05-02 |
| Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3) Liposomal Cyclosporine A 5 mg, Liposomal Cyclosporine A 10 mg - Bronchiolitis Obliterans, Obliterative Bronchiolitis | Phase 3 | Terminated | Zambon SpA | 164 | 2020-03-12 | 2026-04-07 |
| A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4) Liposomal Cyclosporine A, Liposomal Placebo - Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic | Phase 2 | Terminated | Zambon SpA | 6 | 2020-02-11 | 2023-10-03 |
| Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects Voriconazole inhaled, oral voriconazole - Allergic Bronchopulmonary Aspergillosis | Phase 1 | Completed | Zambon SpA | 58 | 2020-02-11 | 2021-11-15 |
| An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD Parkinson's Disease | Completed | Zambon SpA | 1235 | 2019-12-03 | 2024-04-11 | |
| A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers N-acetylcysteine (NAC) - Respiratory Tract Disorders | Phase 1 | Completed | Zambon SpA | 24 | 2019-11-11 | 2021-02-24 |
| 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 |
| A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg, placebo - Respiratory Tract Diseases, Abnormal Mucus Secretions | Phase 3 | Completed | Zambon SpA | 333 | 2019-06-25 | 2025-09-05 |
| FIGHT-RP 1 Extension Study NAC effervescent tablets - Retinitis Pigmentosa | Phase 1 | Active not recruiting | Johns Hopkins University | 30 | 2019-06-24 | 2026-08-07 |
| 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 |
| Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1) Liposomal Cyclosporine A, standard of care - Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant | Phase 3 | Completed | Zambon SpA | 62 | 2019-03-26 | 2025-10-27 |
| Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2) Liposomal Cyclosporine A, Standard of Care - Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant | Phase 3 | Completed | Zambon SpA | 169 | 2019-03-26 | 2026-02-10 |
| Cost-effectiveness of Nursing Interventions for Patients With PD Parkinson's disease nurse specialist care - Parkinson Disease | Not applicable | Completed | Radboud University Medical Center | 242 | 2019-01-07 | 2023-11-22 |
| Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium. CMS, Placebo - Non Cystic Fibrosis Bronchiectasis | Phase 3 | Terminated | Zambon SpA | 287 | 2018-01-29 | 2026-10-15 |
| Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I) CMS, Placebo - Non Cystic Fibrosis Bronchiectasis | Phase 3 | Completed | Zambon SpA | 377 | 2017-06-06 | 2023-11-15 |
| 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 |
Showing 20 of 31. Sign in to see all of them.
Parkinson Disease (5) · Asthma (4) · Bronchiolitis Obliterans (3) · Bronchiolitis Obliterans Syndrome (3) · Bronchitis, Chronic (2) · Pulmonary Disease, Chronic Obstructive (2) · Rejection, Psychology (2) · Anaphylaxis (1) · Aspergillosis, Allergic Bronchopulmonary (1) · Bronchiectasis (1) · Bronchitis (1) · Cough (1) · Cystic Fibrosis (1) · Dyskinesia, Drug-Induced (1) · Idiopathic Pulmonary Fibrosis (1)
safinamide (7) · Acetylcysteine (5) · Budesonide (2) · Budesonide, Formoterol Fumarate Drug Combination (2) · Charcoal (2) · Formoterol Fumarate (2) · Saline Solution (2) · Standard of Care (2) · Adrenal Cortex Hormones (1) · Ambroxol (1) · Analgesics (1) · Anti-Infective Agents (1) · Anti-Inflammatory Agents (1) · Blood Specimen Collection (1) · Diclofenac (1)
Spain (11) · Germany (9) · France (8) · United Kingdom (8) · Belgium (7) · Italy (7) · United States (7) · Israel (5) · China (4) · Netherlands (4) · Switzerland (4) · Austria (3) · Australia (2) · Denmark (2) · Greece (2)
Paola Castellani, MD (5) · Milko Radicioni, MD (4) · Charlotte Keywood, MD (3) · Bastiaan R Bloem, MD, PhD (1) · Bruce K Rubin, MEng,MD,MBA (1) · Carlo Cattaneo (1) · Chris van Weel, MD, PhD (1) · Julian Campo Trapero (1) · M. Demedts, MD (1) · Paola R Castellani, MD (1) · Peter Campochiaro (1)
PMID 16306520, PMID 19860915, PMID 28657769, PMID 31941538, PMID 32609918, PMID 35148289, PMID 36346534, PMID 36967281, PMID 38070039, PMID 38565814, PMID 39918069
2018 (3), 2019 (3), 2014 (2), 2015 (2), 2016 (1), 2017 (1)