Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)

A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223588

Enrollment

Registered

2017-07-14

Start date

2017-06-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Onset Seizures

Interventions

investigational material(s) Generic name etc : E2007 INN of investigational material : Perampanel Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)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 (2)Participants who are newly diagnosed or recurrent epilepsy (3)Participants who have excluded the progressive central nervous system (CNS) abnormality occurring seizures by computed tomography (CT) or magnetic resonance imaging (MRI) (4)Participants who have had a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures

Exclusion criteria

Exclusion criteria: (1)Participants who present only simple partial seizures without motor signs (2)Participants who have seizure clusters where individual seizures cannot be counted (3)Participants who present or have a history of Lennox-Gastaut syndrome (4)Participants who have a history of status epilepticus (5)Participants who have a history of psychogenic non-epileptic seizures

Design outcomes

Primary

Measure	Time frame
efficacy Primary Outcome: The seizure-free rate during 26-week Maintenance Period	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Secondary Outcome: The seizure-free rate in the 52-week treatment	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026