10 completed, 3 terminated, 1 withdrawn. 7 Phase 1, 4 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 6, Withdrawn 1 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
Follow soticlestat: new trials by email Literature Review of soticlestat trials Research Report on soticlestat
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 Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine Soticlestat - Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS) | Phase 3 | Terminated | Takeda | 1 | 2024-04-25 | 2026-09-04 |
| A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience Soticlestat 300 mg, Soticlestat 600 mg, Soticlestat 900 mg - Healthy Volunteers | Phase 1 | Completed | Takeda | 100 | 2022-11-15 | 2026-09-16 |
| A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval Soticlestat, Placebo, Moxifloxacin - Healthy Volunteers | Phase 1 | Withdrawn | Takeda | 2022-10-11 | 2026-08-19 | |
| A Study of Soticlestat Tablets in Healthy Adults Soticlestat - Healthy Volunteers | Phase 1 | Completed | Takeda | 96 | 2022-03-11 | 2026-09-10 |
| A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome Soticlestat - Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS) | Phase 3 | Terminated | Takeda | 352 | 2022-03-04 | 2026-09-04 |
| A Study of Soticlestat and Rifampin in Healthy Adults Soticlestat, Rifampin - Healthy Volunteers | Phase 1 | Completed | Takeda | 15 | 2021-11-22 | 2026-09-10 |
| A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome Placebo, Soticlestat - Lennox Gastaut Syndrome (LGS) | Phase 3 | Completed | Takeda | 270 | 2021-11-08 | 2026-09-10 |
| A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function Soticlestat - Hepatic Impairment, Healthy Volunteers | Phase 1 | Completed | Takeda | 36 | 2021-10-29 | 2026-09-15 |
| A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome Soticlestat, Placebo - Dravet Syndrome (DS) | Phase 3 | Completed | Takeda | 144 | 2021-10-28 | 2026-09-04 |
| A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults Soticlestat, Itraconazole, Mefenamic acid - Healthy Volunteers | Phase 1 | Completed | Takeda | 28 | 2021-10-14 | 2026-09-10 |
| Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution - Healthy Volunteers | Phase 1 | Completed | Takeda | 6 | 2020-07-09 | 2026-09-14 |
| Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS) Soticlestat, Placebo - Complex Regional Pain Syndrome | Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 24 | 2019-07-23 | 2026-09-14 |
| A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY) Soticlestat - 15q Duplication Syndrome, CDKL5 Deficiency Disease | Phase 2 | Completed | Takeda | 20 | 2018-09-10 | 2026-09-10 |
| A Study of Soticlestat in Adults and Children With Rare Epilepsies Soticlestat - Epilepsy, Dravet Syndrome (DS) | Phase 2 | Terminated | Takeda | 156 | 2018-07-19 | 2026-09-04 |
Epilepsies, Myoclonic (4) · Lennox Gastaut Syndrome (4) · Epilepsy (2) · Autistic Disorder (1) · Brain Diseases (1) · CDKL5 deficiency disorder (1) · Central Nervous System Diseases (1) · Complex Regional Pain Syndromes (1) · Polyposis Syndrome, Hereditary Mixed, 1 (1)
Takeda (13) · Millennium Pharmaceuticals, Inc. (1)
United States (10) · Australia (4) · Canada (4) · China (4) · Hungary (4) · Poland (4) · Spain (4) · France (3) · Germany (3) · Greece (3) · Italy (3) · Japan (3) · Latvia (3) · Netherlands (3) · Russia (3)
2018 (1), 2023 (1)