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TAK-935

DRUG6 trials

Sponsors

Takeda

Conditions

Developmental and/or Epileptic EncephalopathiesDravet SyndromeEpilepsyEpilepsy, Molecular Mechanisms of Pharmalogical Action, Protective AgentsHealthy VolunteerHealthy VolunteersLennox-Gastaut Syndrome

Phase 1

Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
CompletedNCT02201056
TakedaHealthy Volunteers
Start: 2014-07-01End: 2015-07-01Updated: 2026-09-15
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
CompletedNCT02497235
TakedaEpilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
Start: 2015-07-01End: 2016-01-01Updated: 2026-09-15
TAK-935 Multiple Rising Dose Study in Healthy Participants
CompletedNCT02539134
TakedaEpilepsy
Start: 2015-09-01End: 2016-04-01Updated: 2026-09-15
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
CompletedNCT03166215
TakedaDevelopmental and/or Epileptic Encephalopathies
Start: 2017-08-17End: 2018-09-19Updated: 2026-09-14
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
CompletedNCT04461483
TakedaHealthy Volunteer
Start: 2020-08-13End: 2020-11-14Updated: 2026-09-16

Phase 2

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
CompletedNCT03650452
TakedaDravet Syndrome, Epilepsy, Lennox-Gastaut Syndrome
Start: 2018-08-08End: 2020-07-20Updated: 2026-09-14

Related Papers

Concentration‐QTc analysis of soticlestat in healthy adults: An alternative to a thorough QT study
British Journal of Clinical Pharmacology2024-09-231 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
Efficacy of Soticlestat Treatment by Seizure Type in Patients with Dravet Syndrome or Lennox–Gastaut Syndrome in a Phase 2, Randomized, Placebo-controlled Study (ELEKTRA) (P11-1.002)
Neurology2023-04-251 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
A phase 1b/2a study of soticlestat as adjunctive therapy in participants with developmental and/or epileptic encephalopathies.
2021-04-2240 citations
Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as Adjunctive Therapy in Pediatric Patients with Dravet Syndrome and Lennox-Gastaut Syndrome (ELEKTRA) (4234)
Neurology2021-04-1310 citations