CompletedPhase 2

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)

United States20 participantsStarted 2018-09-10

Plain-language summary

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.

Who can participate

Age range2 Years – 55 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Two or more episodes of convulsive status epilepticus per 3 months requiring hospitalization and intubation.
✕. Currently receiving a study drug or participated in a clinical study involving another investigational product in the previous month.

What they're measuring

Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Maintenance Period

Timeframe: Maintenance Period: Weeks 9 to 20

Trial details

NCT IDNCT03694275

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-13

Results submitted2021-01-29

View on ClinicalTrials.gov More 15q Duplication Syndrome trials