A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants W… (NCT05533814) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
South Korea125 participantsStarted 2022-10-19
Plain-language summary
The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).
Who can participate
Age range4 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female, age 4 years or older
✓. Diagnosis of epilepsy with FOS with or without FBTCS according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (2017), established by clinical history and an electroencephalogram (EEG)
✓. Newly diagnosed or recurrent epilepsy with at least 2 unprovoked seizures (excluding focal non-motor seizures) separated by a minimum of 24 hours in the 1 year before Visit 1 (baseline)
Exclusion criteria
✕. Focal non-motor seizures only
✕. Generalized epilepsies or seizures such as absences and/or myoclonic seizures, or Lennox Gastaut syndrome
✕. History of status epilepticus within 1 year before Visit 1 (baseline)
✕. History of psychogenic non-epileptic seizures within 5 years before Visit 1 (baseline)
✕. Progressive central nervous system (CNS) disease (including degenerative CNS diseases, progressive tumors, and dementia), or clinically significant psychological or neurological disorders
✕. History of suicidal ideation/attempt within 5 years before Visit 1 (baseline)
✕. Evidence of clinically significant active hepatic disease, or other clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant safety or interfere with the study assessments
What they're measuring
1
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period