Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SK Life Science, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Weight at least 40 kg
A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
Currently on stable antiepileptic treatment regimen.
You may not be if
A history of nonepileptic or psychogenic seizures
Presence of only nonmotor simple partial seizures or primary generalized epilepsies
Presence or previous history of Lennox-Gastaut syndrome
An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
History of alcoholism, drug abuse, or drug addiction within the past 2 years
History of status epilepticus within 3 months of Visit 1
A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
More than 1 lifetime suicide attempt
Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
