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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 11 August 2020
Main ID:  JPRN-JapicCTI-173536
Date of registration: 15/03/2017
Prospective Registration: No
Primary sponsor: Eisai Co., Ltd.
Public title: Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
Scientific title: 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
Date of first enrolment: 13/12/2016
Target sample size: 142
Recruitment status: recruiting
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-173536
Study type:  INTERVENTIONAL
Study design:  Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
 
Phase:  3
Countries of recruitment
Japan, Asia except Japan, North America, Europe, Oceania
Contacts
Name: Eisai Co., Ltd. Inquiry service   
Address: 
Telephone:
Email: https://inquiry.eisai.co.jp/webapp/form/17672_sdab_2/index.do
Affiliation: 
Name: Eisai Co.,Ltd Inquiry service   
Address: 
Telephone:
Email: https://inquiry.eisai.co.jp/webapp/form/17672_sdab_2/index.do
Affiliation: 
Key inclusion & exclusion 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: (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


Age minimum: 2
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome (LGS)
Intervention(s)
Intervention name : E2007
INN of the intervention : Perampanel
Dosage And administration of the intervention : 2 mg oral tablets and 0.5 mg/ml oral suspension
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Matching-placebo
Primary Outcome(s)
efficacy
median percent change in drop seizure frequency per28 days during double-blind treatment
Secondary Outcome(s)
safety
-
Secondary ID(s)
NCT02834793
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 10/02/2017
Contact:
-
Results
Results available:
Date Posted:
Date Completed:
URL:
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