Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223481

Enrollment

142

Registered

2017-03-15

Start date

2016-12-13

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

Lennox-Gastaut Syndrome (LGS)

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)Participants must have a diagnosis of Lennox-Gastaut Syndrome (LGS) (2)Participants must be at least 2 years old at the time of consent. (3)Participants must have been receiving 1 to 3 concomitant antiepileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1 (4)Body weight at least 8 kg.

Exclusion criteria

Exclusion criteria: (1)Presence of progressive neurological disease (2)Presence of drop seizure clusters where individual seizures cannot be reliably counted (3)Prior treatment with perampanel with discontinuation due to safety issues (related to perampanel) (4)Scheduled for epilepsy-related surgery or any other form of surgery during the projected course of the study

Design outcomes

Primary

Measure	Time frame
efficacy median percent change in drop seizure frequency per28 days during double-blind treatment	—

Secondary

Measure	Time frame
safety -	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

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