Soticlestat

DRUG12 trials

Sponsors

Takeda, Millennium Pharmaceuticals, Inc.

Conditions

15q Duplication SyndromeCDKL5 Deficiency DiseaseComplex Regional Pain SyndromeDravet Syndrome (DS)EpilepsyHealthy VolunteersHepatic ImpairmentLennox Gastaut Syndrome (LGS)

Phase 1

A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

CompletedNCT05064449

TakedaHealthy Volunteers

Start: 2021-10-14End: 2021-11-30Updated: 2023-10-03

A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function

CompletedNCT05098054

TakedaHealthy Volunteers, Hepatic Impairment

Start: 2021-10-29End: 2022-06-07Updated: 2024-02-02

A Study of Soticlestat and Rifampin in Healthy Adults

CompletedNCT05098041

TakedaHealthy Volunteers

Start: 2021-11-22End: 2022-03-03Updated: 2023-11-22

A Study of Soticlestat Tablets in Healthy Adults

CompletedNCT05284760

TakedaHealthy Volunteers

Start: 2022-03-11End: 2022-06-02Updated: 2024-02-28

A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval

WithdrawnNCT05309902

TakedaHealthy Volunteers

Start: 2022-10-11End: 2022-12-06Updated: 2022-11-14

Phase 2

A Study of Soticlestat in Adults and Children With Rare Epilepsies

TerminatedNCT03635073

TakedaDravet Syndrome (DS), Epilepsy, Lennox-Gastaut Syndrome (LGS)

Start: 2018-07-19End: 2025-07-30Updated: 2026-03-19

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)

CompletedNCT03694275

Takeda15q Duplication Syndrome, CDKL5 Deficiency Disease

Start: 2018-09-10End: 2020-07-31Updated: 2022-05-26

Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)

CompletedNCT03990649

Millennium Pharmaceuticals, Inc.Complex Regional Pain Syndrome

Start: 2019-07-23End: 2020-10-28Updated: 2021-07-15

Phase 3

A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

CompletedNCT04938427

TakedaLennox Gastaut Syndrome (LGS)

Start: 2021-11-08End: 2024-01-25Updated: 2024-08-21

A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

CompletedNCT04940624

TakedaDravet Syndrome (DS)

Start: 2021-10-28End: 2024-04-11Updated: 2025-01-01

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

TerminatedNCT05163314

TakedaDravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)

Start: 2022-03-04End: 2025-09-24Updated: 2025-10-08

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

TerminatedNCT06422377

TakedaDravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)

Start: 2024-04-25End: 2024-08-14Updated: 2025-07-29

Related Papers

A phase 3, randomized clinical trial of soticlestat as adjunctive therapy for Lennox–Gastaut syndrome

Epilepsia2026-03-27

Soticlestat as an adjunctive therapy in children and young adults with Dravet syndrome.

2026-03-05

Concentration‐QTc analysis of soticlestat in healthy adults: An alternative to a thorough QT study

British Journal of Clinical Pharmacology2024-09-231 citations

Phase 1 pharmacokinetic and safety study of soticlestat in participants with mild or moderate hepatic impairment or normal hepatic function

Pharmacology Research & Perspectives2024-07-115 citations

Effects of Strong Inhibition of Cytochrome P450 3A and UDP glucuronosyltransferase 1A9 and Strong Induction of Cytochrome P450 3A on the Pharmacokinetics, Safety, and Tolerability of Soticlestat: Two Drug–Drug Interaction Studies in Healthy Volunteers

Drug Metabolism and Disposition2023-12-205 citations

Clinical Characterization of [<sup>18</sup>F]T-008, a Cholesterol 24-Hydroxylase PET Ligand: Dosimetry, Kinetic Modeling, Variability, and Soticlestat Occupancy

Journal of Nuclear Medicine2023-09-284 citations

Long-Term Treatment Effects of Soticlestat in Patients with Dravet Syndrome or Lennox–Gastaut Syndrome: Interim Data from the ENDYMION 1 Trial (S44.004)

Neurology2023-04-253 citations

Efficacy, safety, and tolerability of soticlestat as adjunctive therapy for the treatment of seizures in patients with Dup15q syndrome or CDKL5 deficiency disorder in an open-label signal-finding phase II study (ARCADE).

2023-04-0115 citations

A phase 2, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox–Gastaut syndrome (<scp>ELEKTRA</scp>)

Epilepsia2022-07-1670 citations

Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as an Adjunctive Therapy in Patients with 15q Duplication Syndrome (Dup15q) or Cyclin-Dependent Kinase-Like 5 Deficiency Disorder (CDD) in a Signal-Finding Phase 2 Study (ARCADE) (4096)

Neurology2021-04-132 citations