A Study of Intravenous Perampanel in Japanese Participants With Epilepsy

A Multicenter, Uncontrolled, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Perampanel as Substitute for Oral Tablet in Subjects With Partial Onset Seizures (Including Secondarily Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224165

Enrollment

Registered

2018-11-29

Start date

2018-11-27

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

Epilepsy

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.A diagnosis of epilepsy with partial seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981). 2.Receiving a stable dose regimen of oral perampanel. 3.Receiving a concomitant stable dose regimen of marketed antiepileptic drugs (AED[s]). No change of dosing regimen for concomitant AED(s) is planned during the intravenous Treatment and Follow-up Phases. 4.Considered reliable and willing to be available for the study period by the investigator, and are able to record seizures and report adverse events (AEs) by themselves or have a caregiver who can record seizures and report AEs for them.

Exclusion criteria

Exclusion criteria: 1.A history of drug or alcohol dependency or abuse. 2.A history of status epilepticus. 3.Unsuitable for venipuncture and intravenous administration. 4.Requires medical intervention due to safety issues related to concomitant administration of AED(s). 5.A history of suicidal ideation/attempt.

Design outcomes

Primary

Measure	Time frame
safety -Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Pre-treatment phase up to 28 days after participant's last dose of study drug (on Day 32)] -Number of Participants With Adverse Events (AEs) [ Time Frame: Pre-treatment phase up to 21 days after participant's last dose of study drug (on Day 25)]	—

Secondary

Measure	Time frame
efficacy pharmacokinetics -	—

Countries

Japan

Outcome results

None listed

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