Active — Not RecruitingPhase 3

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

United States140 participantsStarted 2022-01-14

Plain-language summary

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Who can participate

Age range2 Years – 18 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

✓. Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
✓. Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039)
✓. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds \[lb\])
✓. Have had a brain imaging (e.g., magnetic resonance imaging \[MRI\] scan or computed tomography (CT) within 10 years before Visit 1 (Screening) that ruled out a progressive cause of epilepsy.
✓. For subjects new to Study YKP3089C040, participants must have had at least 1 POS seizure during the 28-day Baseline Period. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
✓. Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1 (Screening). A vagal nerve stimulator \[VNS\] will not be counted as one of the 3 allowed AEDs but the settings should be stable for at least 4 weeks prior to Visit 1 (Screening).
✓. Investigator believes subject could benefit from new or continued exposure to study drug
✓. Subjects entering from study YKP3089C039 must continue to meet all of the inclusion criteria from the YKP3089C039 study

Exclusion criteria

✕. Females who are breastfeeding or pregnant at Screening or Baseline.
✕. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1 (Screening).
✕. Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 (Screening).
✕. Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1 (Screening), current psychotic disorder, acute mania).
✕. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 \[i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) in participants aged 6 and above, if able\].
✕. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1 (Screening); however, those who have previously documented "failed" epilepsy surgery will be allowed.
✕. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
✕. Presence of only nonmotor simple partial seizures or primary generalized epilepsies.

What they're measuring

Incidence of Adverse Events and SAEs

Timeframe: 3 Years

Trial details

NCT IDNCT05067634

SponsorSK Life Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Partial Epilepsy trials