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Epilepsy Treatment Study (Kayak Study)

Research Question:
Can the investigational drug NBI-921352, which selectively binds with a specific sodium channel, Nav1.6 whose activity is impacted by the SCN8A gene, decrease the frequency of seizures and improve the quality of life for those suffering from a rare form of epilepsy known as SCN8A developmental and epileptic encephalopathy (SCN8A-DEE)?

Basic Study Information

Purpose:
The study, known as the Kayak Study, looks at how the investigational drug affects the symptoms, quality of life, severity of seizures, and frequency of seizures when compared to a placebo (inactive drug) in individuals 2-21 years of age diagnosed with SCN8A-DEE.

Location: University of Rochester
Study Web URL:  http://www.kayakstudy.com
Study Reference #: 00006603

Lead Researcher (Principal Investigator)

Lead Researcher:  Inna Hughes

Study Contact Information

Study Coordinator: Cate Concannon
Phone: (585) 275-0589
Email: Cathleen_Concannon@urmc.rochester.edu

Additional Study Details

Study Details:
The study will last for approximately 24 weeks for participants enrolling in the open-label extension study and approximately 30 weeks (24 weeks plus 2-week taper period and 4-week safety follow-up period) for participants who choose not to enroll in the extension study.

Number of Visits:  6 to 10
Parking:  Reimbursed
Transportation Coverage: 
Reimbursement:  Yes

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