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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - Any
Updated:9/8/2018
Start Date:December 13, 2016
End Date:August 16, 2021
Contact:Eisai Medical Information
Email:esi_medinfo@eisai.com
Phone:1-888-274-2378

Use our guide to learn which trials are right for you!

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

This study is being conducted to demonstrate that perampanel given as adjunctive
anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in
participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome
(LGS).

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of
perampanel as adjunctive therapy in participants with inadequately controlled seizures
associated with LGS. The study will consist of 3 phases: Prerandomization (4 to 8 weeks),
Randomization (22 weeks), and Extension (56 weeks).

Inclusion Criteria:

- Participants must have a diagnosis of Lennox-Gastaut Syndrome (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.

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

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

- Participants must have been receiving 1 to 3 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).

- 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 must have been discontinued at least 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 in the 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 cytochrome P450 (CYP3A)
including, but not limited to: rifampin, troglitazone, St. John's Wort, efavirenz,
nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and
rifabutin

- Use of AEDs not recommended by Epilepsy Treatment Guidelines for use in LGS including,
but not limited to carbamazepine, gabapentin, oxcarbazepine, phenytoin, pregabalin,
tiababine, and vigabatrin

- Concomitant use of cannabinoids
We found this trial at
39
sites
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
?
mi
from
Akron, OH
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
7485 Sandlake Commons Blvd.
Orlando, Florida 32835
?
mi
from
Orlando, FL
Click here to add this to my saved trials
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
Gulf Breeze, Florida 32561
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Livingston, New Jersey
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Loxahatchee Groves, Florida 33470
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
12959 Palms West Drive
Loxahatchee Groves, Florida 33470
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Milwaukee, Wisconsin 53211
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Renton, Washington 98057
?
mi
from
Renton, WA
Click here to add this to my saved trials
222 South Woods Mill Road
Saint Louis, Missouri 63131
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Antonio, Texas 78258
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Wauwatosa, Wisconsin 53226
?
mi
from
Wauwatosa, WI
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials