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.

Clinical Trial Conditions for Soticlestat

Condition Name

Condition Name
Intervention	Trials
Healthy Volunteers	7
Lennox Gastaut Syndrome (LGS)	2
Dravet Syndrome (DS)	2
15q Duplication Syndrome	1

Condition MeSH

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

Clinical Trial Locations for Soticlestat

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Soticlestat

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Soticlestat

Sponsor Name

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

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	13