A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Japanese male or female patients aged 2 to under 18 years at the time of informed consent.

Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.

Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.

Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.

Disqualifiers

Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.

Patients with a history of non-epileptic psychogenic seizures.

Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.

Patients diagnosed with Lennox-Gastaut syndrome.

Trial design

Treatments tested in this trial

  • Cenobamate (tablet) for 12 to < 18 year olds
  • Cenobamate (syrup) for 2 to < 18 year olds

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators