Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Pa… (NCT06453213) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
United States49 participantsStarted 2024-10-14
Plain-language summary
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them.
✓. Male or female subjects 18-74 years of age with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures. Diagnosis will be established by clinical history and an electroencephalogram (EEG) consistent with POS. Subjects with a normal EEG could be included provided they met the other diagnostic criteria according to clinical history.
✓. Subjects who are newly diagnosed or have recurrent epilepsy and have experienced:
✓. At least 2 unprovoked seizures (at least \>24 hours apart) within the 1 year prior to Day 1 of the Treatment Period, of which, at least 1 unprovoked seizure (but below 20 seizures) occurred in the 12 weeks prior to Day 1 of the Treatment Period.
✓. 1 unprovoked seizure within the 12 weeks prior to Day 1 of the Treatment Period with concomitant information to support an increased risk (\>60%) of a second seizure. In the absence of clear information about recurrence risk, or even knowledge of such information, the default definition of epilepsy originates at the second unprovoked seizure.
✓. Female subjects are either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 2 weeks after last dose of study drug.
What they're measuring
1
Seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period
✓. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
✓. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.
Exclusion criteria
✕. Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs.
✕. Subjects who have seizure clusters where individual seizures cannot be counted.
✕. Subjects who present with or have a history of Lennox-Gastaut syndrome.
✕. Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the Treatment Period.
✕. Subjects who have a history of psychogenic non-epileptic seizures within 2 years prior to Day 1 of the Treatment Period.
✕. Subjects who have a history of active suicidal ideation within the last 6 months or suicide attempt within 2 years prior to Day 1 of Treatment Period.
✕. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, psychiatric, other neurological) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
✕. History of Familial Short QT syndrome or prior subject diagnosis of Short QT syndrome.