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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834793
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome (LGS) Drug: Placebo Drug: Perampanel Phase 3

Detailed Description:
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 (18 weeks), and an Extension A (52 weeks). An additional Extension B with open-label treatment will be available for optional participation to participants who reside in Japan and in countries where an expanded access program (EAP) cannot be implemented or has not yet been implemented.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : January 28, 2022
Estimated Study Completion Date : February 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: Perampanel up to 8 mg/day

During the Randomization Phase, participants will receive perampanel at a starting dose of 2 milligrams per day (mg/day). Thereafter, the dose will be increased to a maximum target dose of 8 mg/day according to individual tolerability and efficacy for up to 18 weeks. Participants who enter into Extension A will continue to receive perampanel at the dose last received during randomization phase. Participants can be titrated up to 12 mg/day (at 2-week intervals) per the investigator's discretion.

Participants who continue in Extension B will continue to receive perampanel at the dose last received at the end of Extension A.

Drug: Perampanel
Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B.
Other Name: E2007

Placebo Comparator: Matching placebo

During the Randomization Phase, participants will receive matching placebo for up to 18 weeks.

During the Extension A, participants who received placebo during the Randomization Phase will begin treatment with perampanel in a blinded manner in double-blind Conversion Period, starting at 2 mg/day and then up-titrated to a maximum target dose of 8 mg/day according to individual tolerability and efficacy. After the Conversion Period, participants can be titrated up to 12 mg/day (at 2-week intervals) per the investigator's discretion.

Drug: Placebo
Participants will receive matching placebo in Randomization phase.

Drug: Perampanel
Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B.
Other Name: E2007




Primary Outcome Measures :
  1. 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 ]
    Drop seizures are defined as drop attacks or spells involving the entire body, trunk, or head that lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or that could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.


Secondary Outcome Measures :
  1. 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 ]
    Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.

  2. 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 ]
    Drop seizures are defined as drop attacks or spells involving the entire body, trunk, or head that lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or that could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. The 50% responder rate is defined as the percentage of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase.

  3. 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 ]
    The 50% responder rate is defined as the percentage of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase.

  4. 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 ]
    Non-drop seizures are defined as non-drop attacks or spells. Drop attacks and spells involve the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell. Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) * 100.

  5. 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 ]
  6. 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 ]
    The 50% responder rate is defined as the percentage of participants who have at least a 50% reduction in seizure frequency during the Maintenance Period relative to the Prerandomization Phase. Non-drop seizures are defined as non-drop attacks or spells. Drop attacks and spells involve the entire body, trunk, or head and lead to a fall, injury, slumping in a chair, or the participant's head hitting a surface, or could lead to a fall or injury, depending on the participant's position at the time of the attack or spell.

  7. Physicians' global evaluation of the participant's overall changes in symptoms at the end of double-blind treatment [ Time Frame: up to 18 weeks ]
    The physician evaluated symptoms using a 7-point Likert scale: 1 = very much improved; and 7 = very much worse.

  8. 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 ]
    For this study, the criteria for identifying AEs are: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test (eg, electrocardiogram [ECG] or X-ray) that results in symptoms, a change in treatment, or discontinuation of study drug; recurrence of an intermittent medical condition (eg, headache) not present pretreatment (Baseline); an abnormal laboratory test result should be considered an AE if the identified laboratory abnormality leads to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.

  9. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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, tiagabine, and vigabatrin
  • Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C -SSRS) in participants aged 8 and above.
  • Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834793


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
Hide Hide 90 study locations
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United States, Arizona
Banner - University Medical Center Phoenix Withdrawn
Phoenix, Arizona, United States, 85006
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72202-3500
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
United States, Colorado
Colorado Children's Hospital Withdrawn
Aurora, Colorado, United States, 80045-7106
United States, Connecticut
Yale University Withdrawn
New Haven, Connecticut, United States
United States, Florida
Northwest Florida Clinical Research Group, LLC Recruiting
Gulf Breeze, Florida, United States, 32561
University of Florida Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Pediatric Neurologists of Palm Beach Recruiting
Loxahatchee Groves, Florida, United States, 33470
Axcess Medical Research Recruiting
Loxahatchee Groves, Florida, United States
Nicklaus Children's Hospital Not yet recruiting
Miami, Florida, United States, 33155
Pediatric Neurology PA Recruiting
Orlando, Florida, United States, 32819
University of South Florida Withdrawn
Tampa, Florida, United States, 33606
United States, Georgia
Children's Healthcare of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30342
Meridian Clinical Research Withdrawn
Savannah, Georgia, United States, 31406
United States, Idaho
Consultants In Epilepsy and Neurology PLLC Recruiting
Boise, Idaho, United States, 83702
United States, Illinois
Rush University Medical Center Withdrawn
Chicago, Illinois, United States, 60612
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Mcfarland Clinic PC Withdrawn
Ames, Iowa, United States, 50010-3014
United States, Kentucky
Bluegrass Epilepsy Research LLC Withdrawn
Lexington, Kentucky, United States, 40504-1728
University of Kentucky Withdrawn
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Ochsner Health System Withdrawn
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center Withdrawn
Shreveport, Louisiana, United States, 71103-4225
United States, Maryland
Midatlantic Epilepsy and Sleep Center Recruiting
Bethesda, Maryland, United States, 20817
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Wayne State University Active, not recruiting
Detroit, Michigan, United States, 48201
Mercy Health Saint Mary's Campus Active, not recruiting
Grand Rapids, Michigan, United States, 49301
United States, Minnesota
Minnesota Epilepsy Group PA Terminated
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Comprehensive Epilepsy Care Center For Children and Adults PC Withdrawn
Saint Louis, Missouri, United States, 63131-2308
United States, New Jersey
St Barnabas Institute of Neurology Withdrawn
Livingston, New Jersey, United States, 07039
Children's Hospital at Saint Peter's University Hospital Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
University of North Carolina at Chapel Hill Withdrawn
Chapel Hill, North Carolina, United States, 27514
Wake Forest Baptist Medical Center Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron Children's Hospital Withdrawn
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center - PIN Recruiting
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Lehigh Valley Hospital Withdrawn
Allentown, Pennsylvania, United States, 18103
Thomas Jefferson University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Austin Epilepsy Care Center Not yet recruiting
Austin, Texas, United States, 78758
Road Runner Research Ltd Recruiting
San Antonio, Texas, United States, 78249
Baylor Scott and White Research Institute Not yet recruiting
Temple, Texas, United States, 76508
United States, Utah
Clinical Neurosciences Center Not yet recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Sentara Medical Group Withdrawn
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Rainier Clinical Research Center Inc Withdrawn
Renton, Washington, United States, 98057
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Columbia Saint Mary's Active, not recruiting
Milwaukee, Wisconsin, United States, 53211
Medical College of Wisconsin Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
Australia, Queensland
Queensland Children's Hospital Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Austin Health Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Australia
Royal Brisbane & Women's Hospital Recruiting
Brisbane, Australia
Royal Melbourne Hospital Recruiting
Melbourne, Australia
St Vincent's Hospital Melbourne Not yet recruiting
Melbourne, Australia
The Alfred Hospital Recruiting
Melbourne, Australia
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Brussels, Belgium, 1200
Hôpital Universitaire des Enfants Reine Fabiola Recruiting
La Louvière, Hainaut, Belgium
Hôpital Erasme Recruiting
Bruxelles, Belgium
UZ Brussel Recruiting
Jette, Belgium
Centre Neurologique William Lennox Recruiting
Ottignies-Louvain-la-Neuve, Belgium
Czechia
Fakultni nemocnice Ostrava Not yet recruiting
Poruba, Czechia
Thomayerova nemocnice Not yet recruiting
Praha, Czechia
India
Synexus Affiliate - Panchshil Hospital Not yet recruiting
Ahmedabad, Gujarat, India
Synexus Affiliate - Nirmal Hospitals Pvt. Ltd Recruiting
Surat, Gujarat, India
Synexus Affiliate - Mallikatta Neuro Center Not yet recruiting
Mangalore, Karnataka, India
Synexus Affiliate - Amrita Institute of Medical Sciences and Research Centre Not yet recruiting
Kochi, Kerala, India
Lokmanya Tilak Municipal Medical College and General Hospital Withdrawn
Mumbai, Maharashtra, India, 400022
Synexus Affiliate - Jaslok Hospital and Research Centre Not yet recruiting
Mumbai, Maharashtra, India
Synexus Affiliate - Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute Not yet recruiting
Mumbai, Maharashtra, India
Synexus Affiliate - Bharati Hospital Not yet recruiting
Pune, Maharashtra, India
Nizams Institute of Medical Sciences Not yet recruiting
Hyderabad, India, 500082
Synexus Affiliate - Sir Ganga Ram Hospital Not yet recruiting
New Delhi, India
Japan
Eisai Trial Site #1 Recruiting
Fukuoka, Japan
Eisai Trial Site #3 Recruiting
Fukuoka, Japan
Eisai Trial Site #5 Withdrawn
Gifu, Japan
Eisai Trial Site #7 Recruiting
Hakodate, Japan
EIsai Trial Site #9 Not yet recruiting
Kagoshima-city, Japan
Eisai Trial Site #10 Withdrawn
Nagoya, Japan
Eisai Trial Site #4 Recruiting
Niigata, Japan
EIsai Trial Site #8 Recruiting
Osaka, Japan, 534-0021
Eisai Trial Site #6 Recruiting
Sapporo, Japan
Eisai Trial Site #2 Recruiting
Shizuoka, Japan
Korea, Republic of
Kyungpook National University Chilgok hospital Recruiting
Daegu, Korea, Republic of
Gachon University Gil Medical Center Withdrawn
Incheon, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - PPDS Withdrawn
Seoul, Korea, Republic of
Samsung Medical Center - PPDS Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital Withdrawn
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02834793    
Other Study ID Numbers: E2007-G000-338
2014-002321-35 ( EudraCT Number )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
Lennox-Gastaut Syndrome (LGS)
Inadequately controlled seizures
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Seizures
Syndrome
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Genetic Diseases, Inborn