Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
NCT ID: NCT05219617
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
252 participants
INTERVENTIONAL
2022-04-28
2028-12-31
Brief Summary
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Detailed Description
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* To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS)
* Evaluate the safety, tolerability of carisbamate in the LGS population
* Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Carisbamate 200 mg BID arm
Age: 4 to \<12y\* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID
Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID
Carisbamate
Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]).
Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Carisbamate 300 mg BID arm
Age: 4 to \<12y\* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID
Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID
Carisbamate
Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]).
Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Placebo matched to 200 mg BID arm
Age: 4 to \<12y\* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID
Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID
Carisbamate
Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]).
Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Placebo matched to 300 mg BID arm
Age: 4 to \<12y\* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID
Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID
Carisbamate
Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]).
Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Interventions
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Carisbamate
Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]).
Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).
Eligibility Criteria
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Inclusion Criteria
1. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \<3.0 Hz)
3. History of developmental delay
2. Male or female subjects
3. Subjects must be age 4-55 years at the time of consent/assent
4. Must have been \<11 years old at the onset of LGS
5. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).
6. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
7. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
8. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
9. Parents or caregivers must be able to keep accurate seizure diaries
10. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.
11. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study
12. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
13. History of COVID-19 vaccination is permitted
Exclusion Criteria
2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
5. Current use of felbamate with less than 18 months of continuous exposure
6. Concomitant use of vigabatrin: subjects 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, if able.
7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
8. Status epilepticus within 12 weeks prior to Visit 1
9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
10. Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)
11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms \[DRESS\]) or any drug-related rash requiring hospitalization
12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated \<5 months year prior to enrollment. Stimulation parameters that have been stable for \<4 weeks, or Battery life of unit not anticipated to extend for duration of trial.
13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant
14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated
15. Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
16. 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 x ULN
17. Subject with total bilirubin \[TBL\] \>2 x ULN (except for Gilbert's syndrome).
18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)
20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
22. Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)
23. Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin
24. Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome
25. Subject with a short QTc interval (\<340 msec) or long QTc interval (\>460 msec) as confirmed by a repeated electrocardiogram (ECG)
26. Benzodiazepine rescue administered on average more than once a week in the month before Visit 1
27. Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.
4 Years
55 Years
ALL
No
Sponsors
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SK Life Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Kamin, MD
Role: STUDY_DIRECTOR
SK Life Science, Inc.
Locations
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Stanford University Hospital
Palo Alto, California, United States
University of Florida Health Science Center
Jacksonville, Florida, United States
AdventHealth
Orlando, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Axcess Medical Research
Wellington, Florida, United States
Consultants in Epilepsy and Neurology PLLC
Boise, Idaho, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri School of Medicine
Columbia, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
St. Peters Hospital
New Brunswick, New Jersey, United States
Montefiore
The Bronx, New York, United States
Duke University Clinical Research at Pickett Road
Durham, North Carolina, United States
Wake Forest University - School of Medicine
Winston-Salem, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Austin Epilepsy Care Center - Clinic/Outpatient Facility
Austin, Texas, United States
Neurology Consultants of Dallas, PA - Hospital
Dallas, Texas, United States
Virginia Epilepsy and Neurodevelopmental Clinic at WNC
Winchester, Virginia, United States
Hospital de Ninos de La Santisma Trinidad
Córdoba, Córdoba Province, Argentina
Resolution Psychopharmacology Research Institute
Mendoza, Mendoza Province, Argentina
Austin Hosptial
Heidelberg, , Australia
Alfred Health
Melbourne, , Australia
Perth's Children Hospital
Nedlands, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
Fundacion Hospital Universidad del Norte
Barranquilla, , Colombia
Fundacion Valle del Lili/Clinic - Outpatient
Cali, , Colombia
CliniSalud del Sur S.A.S - Centro de Investigación
Envigado, , Colombia
Hospital Pabloe Tubon Uribe
Medellín, , Colombia
Institutio Neurologico de Colombia
Medellín, , Colombia
Universitatsklinikum Erangen
Erlangen, Bavaria, Germany
Kleinwachau Sächsisches Epilepsiezentrum
Radeberg, Saxony, Germany
Iaso Children's Hospital
Marousi, Attica, Greece
Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet
Budapest, , Hungary
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
Budapest, , Hungary
Tela Viv Sourlasky Medical Center
Tel Aviv, Tel Aviv, Israel
Soroka University Medical Centre
Beersheba, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, Italy
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
Milan, Lombardy, Italy
Fondazione IRCCS Di Rilievo Nazionale Instituto
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Verona, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, , Italy
ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo
Milan, , Italy
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, , Mexico
Clinstile, S.A. de C.V.
Mexico City, , Mexico
Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, , Poland
Centro Hospitalar de Lisboa Norte, EPE
Lisbon, Lisbon District, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
Lisbon, Lisbon District, Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, Porto District, Portugal
Hospital Garcia de Orta
Almada, Setúbal District, Portugal
Childrens University Hospital
Belgrade, Belgrade, Serbia
University Clinical Center of Serbia - PPDS
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, , Serbia
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, , Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Arkady Barber
Role: primary
Anna Sakovics, MD
Role: primary
Tatjana Redzek Mudrinic, MD
Role: primary
Other Identifiers
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YKP509C003
Identifier Type: -
Identifier Source: org_study_id
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