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Last Updated: July 16, 2024

CLINICAL TRIALS PROFILE FOR SOTICLESTAT


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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.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Soticlestat

Condition Name

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

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

Trials by Country

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

Trials by US State
Location Trials
Texas 3
Florida 3
Arizona 3
New York 3
Georgia 3
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Clinical Trial Progress for Soticlestat

Clinical Trial Phase

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

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

Sponsor Name

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

Sponsor Type
Sponsor Trials
Industry 13
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