A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Seizures; Epilepsies, Partial
Intervention: YKP3089; Placebo
Intervention MeSH terms: Cenobamate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with
      an 8-week prospective baseline and an 18 week double-blind treatment period (including a
      6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study
      drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for
      subjects who will participate in the open-label extension).

      The primary objective of this study is to determine the effective dose range of YKP3089 as
      adjunctive therapy for the treatment of partial seizures.

      The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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)

          -  A history of any previous exposure to YKP3089