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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)
Sponsor: Takeda
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.
Official title: A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)
Key Details
Gender
All
Age Range
2 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2018-09-10
Completion Date
2020-07-31
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Soticlestat
TAK-935 tablets
Locations (8)
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