A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Intervention: Placebo; E2730
Intervention description: Participants will receive E2730-matched placebo capsule, orally.; Participants will receive E2730 capsule, orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: E2730; Epilepsy; Photosensitive; Seizures; PPR; Anti-epileptic

Summary:

      The primary purpose of the study is to assess the pharmacodynamic (PD) activity of E2730 as
      measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most
      sensitive eye condition in participants with photosensitive epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 to 60 years old at the time of informed consent.

          2. A diagnosis and history of a PPR on EEG with or without a diagnosis of epilepsy.

          3. Currently taking up to a maximum of 3 concomitant antiepileptic drugs (AEDs). If
             taking concomitant AED(s), the dose must have remained stable for at least 4 weeks
             prior to Screening.

          4. A reproducible intermittent photic stimulation (IPS)-induced PPR on EEG of at least 3
             points on a frequency assessment scale (SPR) in at least 1 eye condition on at least 3
             of the EEGs performed at Screening.

          5. A body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2) and a
             total body weight greater than or equal to 45 kilograms (kg) at the time of Screening.

        Exclusion Criteria:

          1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
             positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin
             [hCG]) test with a minimum sensitivity of 25 international units per liter [IU/L] or
             equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a
             negative screening pregnancy test was obtained more than 72 hours before the first
             dose of study drug.

          2. History of nonepileptic seizures (eg, metabolic, structural, or pseudoseizures) while
             on any antiepileptic medication(s).

          3. History of status epilepticus while on any antiepileptic medication(s) within 2 years
             prior to Screening.

          4. Ongoing or history of generalized tonic-clonic seizures within 6 months prior to
             Screening.

          5. Previously developed or who experienced a clinical seizure during prior PPR assessment
             or Screening IPS procedure, respectively.

          6. Use of AEDs that affect gama-aminobutyric acid (GABA) (GABAergic AEDs) (such as
             tiagabine, vigabatrin, gabapentin, pregabalin) within 3 months prior to Screening.

          7. Multiple drug allergies or a severe drug reaction to AED(s), including dermatological
             (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.

          8. An active central nervous system (CNS) infection, demyelinating disease, degenerative
             neurological disease or any CNS disease deemed to be progressive during the course of
             the study that may confound the interpretation of the study results.

          9. Concomitant use of cannabinoids.

         10. Inability to follow restriction on watching television, or use of any device with an
             animated screen (ie, computer, video games, tablets).

         11. A history of prolonged QT syndrome or risk factors for torsade de pointes (eg, heart
             failure, hypokalemia, family history of long QT Syndrome), or the use of concomitant
             medications that prolonged the QT/corrected QT (QTc) interval; or prolonged QT/QTc
             interval (QTc greater than [>] 450 millisecond [msec]) demonstrated on
             electrocardiograms (ECG) at Screening or baseline (based on average of triplicate
             ECGs).

         12. Any suicidal ideation with intent with or without a plan within 6 months before
             Screening or during Screening (ie, answering "Yes" to questions 4 or 5 on the suicidal
             ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS]).

         13. Any lifetime suicidal behavior (per the suicidal behavior section of the C-SSRS).

         14. Any psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use
             of antipsychotics or prior suicide attempt(s) within approximately the last 2 years.

         15. Frequent spontaneous background burst or current evidence of proconvulsive activity on
             EEG (eg, increase in spike-wave activity) at Screening.