CLINICAL TRIALS PROFILE FOR SOTICLESTAT

Clinical Trials for Soticlestat

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03694275 ↗	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)	Completed	Ovid Therapeutics Inc.	Phase 2	The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
NCT03694275 ↗	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)	Completed	Takeda	Phase 2	The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
NCT03990649 ↗	Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	The purpose of this study is to investigate the effect of soticlestat (TAK-935) on calculated 24-hour average pain intensity by the numeric pain scale (NPS).
NCT04938427 ↗	A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome	Recruiting	Takeda	Phase 3	The aims of the study are: - to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. - to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard anti-seizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.
NCT04940624 ↗	A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome	Recruiting	Takeda	Phase 3	The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with Dravet Syndrome. Participants will receive their standard anti-seizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.
NCT04992442 ↗	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	Completed	Takeda	Phase 1	The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite [M-I (N-oxide)] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) [14C]TAK-935 in Treatment Period 2.
NCT05064449 ↗	A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults	Recruiting	Takeda	Phase 1	The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.

Clinical Trial Conditions for Soticlestat

Condition Name

Condition Name for
Intervention	Trials
Healthy Volunteers	7
Lennox Gastaut Syndrome (LGS)	2
Dravet Syndrome (DS)	2
Hepatic Impairment	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Syndrome	5
Lennox Gastaut Syndrome	2
Epilepsies, Myoclonic	2
Somatoform Disorders	1

Clinical Trial Locations for Soticlestat

Trials by Country

Trials by Country for
Location	Trials
United States	36
Japan	18
China	15
Poland	6
Belgium	5

Trials by US State

Trials by US State for
Location	Trials
Texas	3
Florida	3
Arizona	3
New York	3
Georgia	3

Clinical Trial Progress for Soticlestat

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2
Phase 1	7

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	4
Completed	3

Clinical Trial Sponsors for Soticlestat

Sponsor Name

Sponsor Name for
Sponsor	Trials
Takeda	11
Ovid Therapeutics Inc.	1
Millennium Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	13