9 completed, 2 withdrawn, 1 available, 1 terminated. 6 Phase 3, 2 Phase 1, 2 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Terminated 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 1, Withdrawn 1 |
| Phase 4 | 1 | Unknown 1 |
Follow rufinamide: new trials by email Literature Review of rufinamide trials Research Report on rufinamide
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 |
|---|---|---|---|---|---|---|
| Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects Quizartinib, Rufinamide - Healthy Subjects | Phase 1 | Completed | Daiichi Sankyo | 32 | 2024-10-29 | 2024-12-18 |
| Population Pharmacokinetics of Antiepileptic in Pediatrics Valproic acid, carbamazepine, phenobarbital - Epilepsy | Completed | Assistance Publique - Hôpitaux de Paris | 753 | 2017-06-19 | 2025-11-20 | |
| Ketogenic Diet in Infants With Epilepsy (KIWE) Ketogenic diet, Antiepileptic drug therapy - Epilepsy | Phase 4 | Unknown | University College, London | 160 | 2015-01-01 | 2017-05-04 |
| Pharmacokinetics and Tolerability of Rufinamide in Healthy Chinese Subjects rufinamide - Seizures | Phase 1 | Completed | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 40 | 2014-03-01 | 2015-01-06 |
| Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome Rufinamide - Peripheral Nerve Injuries, Pain | Phase 2 | Withdrawn | University of Zurich | 2014-03-01 | 2015-07-21 | |
| Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome Rufinamide - Lennox-Gastaut Syndrome | Completed | Eisai Co., Ltd. | 707 | 2013-06-13 | 2023-02-21 | |
| Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs Rufinamide, Any other approved Antiepileptic Drug - Lennox-Gastaut Syndrome | Phase 3 | Completed | Eisai Inc. | 37 | 2011-06-16 | 2019-08-06 |
| A Long Term Extension Study of E2080 in Lennox-Gastaut Patients Rufinamide - Lennox-Gastaut Syndrome | Phase 3 | Completed | Eisai Co., Ltd. | 54 | 2010-11-01 | 2019-03-11 |
| A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) Rufinamide (E2080), Placebo - Lennox-Gastaut Syndrome | Phase 3 | Completed | Eisai Limited | 66 | 2010-06-01 | 2018-01-24 |
| Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD) SYN111, Placebo - Generalized Anxiety Disorder | Phase 2 | Completed | Biotie Therapies Inc. | 239 | 2008-03-01 | 2019-02-27 |
| Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures Rufinamide - Refractory Partial Onset Seizures | Phase 3 | Terminated | Eisai Inc. | 286 | 2007-03-15 | 2019-11-22 |
| Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures Rufinamide - Refractory Partial Seizures | Phase 3 | Withdrawn | University of South Alabama | 2006-04-01 | 2020-09-22 | |
| Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures Placebo, Rufinamide - Epilepsy | Phase 3 | Completed | Eisai Inc. | 356 | 2006-02-13 | 2021-06-14 |
| An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 Rufinamide - Lennox Gastaut Syndrome | Available | Eisai Inc. | 2026-07-08 |
Epilepsy (8) · Lennox Gastaut Syndrome (5) · Seizures (5) · Brain Diseases (1) · Epileptic encephalopathy, Lennox-Gastaut type (1) · Generalized Anxiety Disorder (1) · Pain (1) · Peripheral Nerve Injuries (1)
Eisai Inc. (4) · Eisai Co., Ltd. (2) · Assistance Publique - Hôpitaux de Paris (1) · Biotie Therapies Inc. (1) · Daiichi Sankyo (1) · Eisai Limited (1) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (1) · University College, London (1) · University of South Alabama (1) · University of Zurich (1)
United States (6) · Japan (3) · France (2) · Poland (2) · Canada (1) · Greece (1) · Italy (1) · South Africa (1) · Switzerland (1) · United Kingdom (1)
Hiroki Takano (2) · Alexis Arzimanoglou Arzimanoglou (1) · Christpher Kenney, MD (1) · Helen Cross, FRCP(UK) (1) · Konrad Maurer, MD (1) · Paul Maertens, MD (1) · Weiyong Li, PhD (1)
PMID 33179247, PMID 33825230, PMID 26805435, PMID 28446244, PMID 30309816, PMID 31168494
2016 (2)