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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: ClinicalTrials.gov
Last refreshed on: 1 March 2021
Main ID:  NCT02834793
Date of registration: 13/07/2016
Prospective Registration: Yes
Primary sponsor: Eisai Inc.
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: December 13, 2016
Target sample size: 142
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02834793
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Austria Belgium Czechia India Japan Korea, Republic of United States
Contacts
Name:     Eisai Medical Information
Address: 
Telephone: 1-888-274-2378
Email: esi_medinfo@eisai.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants must have a diagnosis of LGS as evidenced by:

1. more than one type of generalized seizure, including drop seizures (atonic,
tonic, or myoclonic) for at least 6 months before Visit 1;

2. an electroencephalogram (EEG) reporting diagnostic criteria for LGS at some point
in their history (abnormal background activity accompanied by slow, spike, and
wave pattern <2.5 Hz).

- Participants must be at least 2 years old at the time of consent/assent

- Participants must have been <11 years old at the onset of LGS

- Participants must have experienced an average of at least 2 drop seizures per week in
the 4-week Baseline Period preceding randomization

- Participants must have been receiving 1 to 4 concomitant antiepileptic drugs (AEDs) at
a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation (VNS) and
ketogenic diet do not count as AEDs). Use of cannabidiol (CBD) products is allowed and
is counted as one of the 4 maximum allowed concomitant AEDs. CBD dose and product must
have remained stable for at least 30 days before Visit 1 and is to remain the same
throughout the course of the Core Study

- In the investigator's opinion, parents or caregivers must be able to keep accurate
seizure diaries

- Body weight at least 8 kg

Exclusion Criteria:

- Presence of progressive neurological disease

- Presence of drop seizure clusters where individual seizures cannot be reliably counted
(seizure clusters are defined as =2 drop seizures with <5 minutes between any 2
consecutive seizures)

- Prior treatment with perampanel with discontinuation due to safety issues (related to
perampanel)

- Prior treatment with perampanel within 30 days before Visit 1

- Evidence of clinically significant disease (eg, cardiac, respiratory,
gastrointestinal, renal disease, hepatic disease) that in the opinion of the
investigator(s) could affect the participant's safety or study conduct

- Scheduled for epilepsy-related surgery or any other form of surgery during the
projected course of the study

- Ketogenic diet and VNS, unless stable and ongoing for at least 30 days before Visit 1

- Treatment with an investigational drug or device within 30 days before Visit 1

- Status epilepticus within 12 weeks of Visit 1

- If felbamate is used as a concomitant AED, participants must be on felbamate for at
least 1 year, with a stable dose for 60 days before Visit 1. They must not have a
history of white blood cell (WBC) count below =2500/microliters (µL), platelets
<100,000/µL, liver function tests (LFTs) >3 times the upper limit of normal (ULN), or
other indication of hepatic or bone marrow dysfunction while receiving felbamate

- Concomitant use of vigabatrin: participants who took vigabatrin in the past must be
discontinued for at least 5 months before Visit 1, and must have documentation showing
no evidence of a vigabatrin-associated clinically significant abnormality in an
automated visual perimetry test

- Have had multiple drug allergies or a severe drug reaction to an AED(s), including
dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity
reactions

- Evidence of significant active hepatic disease. Stable elevations of liver enzymes,
alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to
concomitant medication(s) will be allowed if they are < 3 times the ULN

- Adrenocorticotropic hormone within the 6 months before Visit 1

- Had history of anoxic episodes requiring resuscitation within 6 months before Visit 1

- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
positive beta human chorionic gonadotropin [ß-hCG] 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.

- Females of childbearing potential who: a. had unprotected sexual intercourse within 30
days before study entry and who do not agree to use a highly effective method of
contraception (eg, total abstinence, an intrauterine device, a double-barrier method
[such as condom plus diaphragm with spermicide], a contraceptive implant, an oral
contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout
the entire study period or for 28 days after study drug discontinuation. Females using
hormonal contraceptives containing levogesterol must be on another form of
contraception as well. b. Are currently abstinent, and do not agree to use a
double-barrier method (as described above) or refrain from sexual activity during the
study period or for 28 days after study drug discontinuation. c. Are using hormonal
contraceptives but are not on a stable dose of the same hormonal contraceptive product
for at least 4 weeks before dosing and who do not agree to use the same contraceptive
during the study or for 28 days after study drug discontinuation. (NOTE: All females
will be considered to be of childbearing potential unless they are postmenopausal
[amenorrheic for at least 12 consecutive months, in the appropriate age group, and
without other known or suspected cause] or have been sterilized surgically [i.e.,
bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with
surgery at least 1 month before dosing])

- Had intermittent use of benzodiazepine of more than 4 single administrations in the
month before Visit 1

- A prolonged QT/QTc interval (QTc >450 milliseconds [ms]) as demonstrated by a repeated
electrocardiogram (ECG)

- Hypersensitivity to the study drug or any of the excipients

- Any history of a medical condition or a concomitant medical condition that in the
opinion of the investigator(s) would compromise the participant's ability to safely
complete the study

- Known to be human immunodeficiency virus (HIV) positive

- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening

- 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

- History of drug or alcohol dependency or abuse within approximately the last 2 years;
use of illegal recreational drugs

- Concomitant use of medications known to be inducers of



Age minimum: 2 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome (LGS)
Intervention(s)
Drug: Perampanel
Drug: Placebo
Primary Outcome(s)
Median percent change in drop seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [Time Frame: up to 18 weeks]
Secondary Outcome(s)
Median percent change in non-drop seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [Time Frame: up to 18 weeks]
Median percent change in total seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase [Time Frame: up to 18 weeks]
Model-derived average perampanel concentrations at steady state (Cav,ss) during the Maintenance Period of the Core Study [Time Frame: Days 43, 78, and 126; upon early discontinuation]
Number of Participants with any Adverse Events (AEs), Serious Adverse Events (SAEs), Changes in Clinical Laboratory Values, and Vital Signs [Time Frame: up to 86 weeks]
Physicians' global evaluation of the participant's overall changes in symptoms at the end of double-blind treatment [Time Frame: up to 18 weeks]
Proportion of participants with 50% response in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for drop seizures [Time Frame: up to 12 weeks]
Proportion of participants with 50% response in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for non-drop seizures [Time Frame: up to 12 weeks]
Proportion of participants with 50% response in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for total seizures [Time Frame: up to 12 weeks]
Proportion of participants with 75% and 100% response in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for drop, non-drop, and total seizures [Time Frame: up to 12 weeks]
Secondary ID(s)
2014-002321-35
E2007-G000-338
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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