TAK-935: Clinical Trials

14 completed, 3 terminated, 1 withdrawn. 10 Phase 1, 5 Phase 2, 4 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	10	Completed 9, Withdrawn 1
Phase 2	5	Completed 4, Terminated 1
Phase 3	4	Completed 2, Terminated 2

Follow TAK-935: new trials by email Literature Review of TAK-935 trials Research Report on TAK-935

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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 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Healthy Adults To Evaluate the Effect on QTc Interval Soticlestat, Placebo, Moxifloxacin - Healthy Volunteers	Phase 1	Withdrawn	Takeda		2022-10-11	2026-08-19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
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants TAK-935, Placebo - Healthy Volunteer	Phase 1	Completed	Takeda	33	2020-08-13	2026-09-16
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 Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies TAK-935, Placebo - Epilepsy, Dravet Syndrome	Phase 2	Completed	Takeda	141	2018-08-08	2026-09-14
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
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies TAK-935, Placebo - Developmental and/or Epileptic Encephalopathies	Phase 1 / Phase 2	Completed	Takeda	18	2017-08-17	2026-09-14
TAK-935 Multiple Rising Dose Study in Healthy Participants TAK-935, Placebo - Epilepsy	Phase 1	Completed	Takeda	40	2015-09-01	2026-09-15
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935 TAK-935, [18F]MNI-792 (tracer) - Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents	Phase 1	Completed	Takeda	11	2015-07-01	2026-09-15
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935 TAK-935, Placebo - Healthy Volunteers	Phase 1	Completed	Takeda	48	2014-07-01	2026-09-15

Conditions studied

Epilepsies, Myoclonic (5)  ·  Epilepsy (5)  ·  Lennox Gastaut Syndrome (5)  ·  Brain Diseases (2)  ·  CDKL5 deficiency disorder (2)  ·  Central Nervous System Diseases (2)  ·  Autistic Disorder (1)  ·  Complex Regional Pain Syndromes (1)  ·  Hypoxia-Ischemia, Brain (1)  ·  Malformations of Cortical Development (1)  ·  Nervous System Diseases (1)  ·  Polyposis Syndrome, Hereditary Mixed, 1 (1)  ·  Seizures (1)  ·  Spasms, Infantile (1)  ·  Tuberous Sclerosis (1)

Sponsors

Takeda (17)  ·  Millennium Pharmaceuticals, Inc. (1)

Countries

United States (13)  ·  Australia (5)  ·  Canada (5)  ·  China (5)  ·  Poland (5)  ·  Spain (5)  ·  Hungary (4)  ·  Japan (4)  ·  France (3)  ·  Germany (3)  ·  Greece (3)  ·  Italy (3)  ·  Latvia (3)  ·  Netherlands (3)  ·  Russia (3)

Results publications

PMID 33940389, PMID 35841234, PMID 36538782, PMID 37011526, PMID 37770111

NIH funding

2018 (2), 2023 (1)