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 · Phase 2

Conditions studied: 15q Duplication Syndrome, CDKL5 Deficiency Disease

In brief

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.

Key facts

Study ID

NCT03694275

Run by

Takeda

People needed

20

Starts

2018-09-10

Expected to finish

2020-07-31

Last updated by the study team

2022-05-26

Who can join

Age: 2 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• UCLA — Los Angeles, California, United States
• Research Institute Children's Hospital Colorado — Aurora, Colorado, United States
• Center for Rare Neurological Diseases — Norcross, Georgia, United States
• Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital Translational Neuroscience Center — Boston, Massachusetts, United States
• Minnesota Epilepsy Group, P.A. — Saint Paul, Minnesota, United States
• New York University (NYU) — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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