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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)
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)

NCT03694275

CompletedPhase 2

Sponsor: Takeda

Conditions: 15q Duplication Syndrome, CDKL5 Deficiency Disease

Interventions: Soticlestat

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.
2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.

Exclusion Criteria:

1. Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation.
2. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.
Locations (8)
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Norcross, Georgia, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Saint Paul, Minnesota, United States
  • New York, New York, United States
  • New York, New York, United States