Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With Lennox Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension
Led by SK Life Science, Inc. · Updated on 2025-07-24
252
Participants Needed
71
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of carisbamate (YKP509) as an additional treatment to reduce drop seizures in children and adults aged 4 to 55 years with Lennox Gastaut Syndrome (LGS). This trial aims to compare carisbamate to a placebo in lowering the number of tonic, atonic, and tonic-clonic seizures. Secondary goals include assessing the overall seizure reduction, safety, tolerability, and how the drug behaves in the body. Participants receive carisbamate or placebo twice daily with doses adjusted based on age and weight. Children aged 4 to under 12 years receive weight-based dosing, while those 12 years and older follow fixed dosing schedules. The study includes a titration period to reach maintenance doses. Some participants may join an optional open-label extension. The study is randomized and double-blind, meaning neither participants nor researchers know who receives carisbamate or placebo. During the trial, participants and caregivers will track seizures using diaries. Regular assessments will measure seizure frequency changes over time, including the primary outcome of percentage change in drop seizures during the double-blind period lasting up to three years. Researchers will also evaluate global impressions of change and monitor safety through clinical evaluations. The total study duration includes baseline, treatment, and follow-up periods, ensuring thorough monitoring of effects and safety.
CONDITIONS
Brief Title
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of Lennox Gastaut Syndrome with multiple seizure types including at least one atonic or tonic seizure
- Electroencephalogram (EEG) showing diagnostic features of LGS
- History of developmental delay
- Male or female subjects
- Age between 4 and 55 years at consent/assent
- Onset of LGS before age 11
- At least 2 drop seizures with potential to cause a fall during 4-week baseline period
- Receiving 1 to 4 stable anti-seizure medications for at least 4 weeks before study start
- Stable dietary therapy and CNS stimulator settings for 4 weeks prior to baseline if applicable
- Ability of parents or caregivers to keep accurate seizure diaries
- If of childbearing potential, must use acceptable birth control methods before and after the study
- Willing and able to give informed consent/assent
- Willing and able to comply with study requirements
- History of COVID-19 vaccination allowed
You will not qualify if you...
- Seizures caused by progressive neurologic disease (except stable tuberous sclerosis without brain tumor)
- Significant medical conditions affecting safety or study conduct
- Use of adrenocorticotropic hormone (ACTH) within 6 months prior to baseline
- Dietary therapy less than 4 weeks before screening or frequent stooling
- Current use of felbamate with less than 18 months continuous exposure
- Use of vigabatrin within 5 months prior to screening or abnormal visual field test
- History of hypoxia requiring emergency resuscitation within 12 months prior to baseline
- Status epilepticus within 12 weeks prior to screening
- Significant illness including COVID-19 within 4 weeks prior to screening
- Clinically significant abnormal lab values at screening or randomization
- History of serious drug-induced hypersensitivity or rash requiring hospitalization
- Recent neurostimulation device implantation or unstable stimulation parameters
- Pregnant, lactating, or planning pregnancy
- Recent suicidal ideation or behavior
- Significant active liver disease or abnormal liver tests beyond allowed levels
- Active viral hepatitis B or C
- History of HIV infection
- Use of other cannabidiol products if taking Epidiolex
- Planned epilepsy surgery or neurostimulation during study
- Use of investigational drugs or devices within 4 weeks prior to screening
- Use of strong cytochrome P450 inducers
- History of significant cardiac disease or abnormal QT intervals
- Frequent use of benzodiazepine rescue medication
- Previous exposure or allergy to carisbamate or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive carisbamate or placebo as an adjunctive treatment to reduce seizures associated with Lennox Gastaut Syndrome.
Regular visits throughout the treatment period
Trial Site Locations
Total: 71 locations
1
Stanford University Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
2
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
Completed
3
AdventHealth
Orlando, Florida, United States, 32803
Completed
4
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States, 33609
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33620
Completed
6
Axcess Medical Research
Wellington, Florida, United States, 33414
Completed
7
Consultants in Epilepsy and Neurology PLLC
Boise, Idaho, United States, 83702
Completed
8
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States, 40504
Completed
9
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Completed
10
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
11
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
Actively Recruiting
12
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
13
University of Missouri School of Medicine
Columbia, Missouri, United States, 65211
Completed
14
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Actively Recruiting
15
St. Peters Hospital
New Brunswick, New Jersey, United States, 08901
Completed
16
Montefiore
The Bronx, New York, United States, 10467
Completed
17
Duke University Clinical Research at Pickett Road
Durham, North Carolina, United States, 27713
Actively Recruiting
18
Wake Forest University - School of Medicine
Winston-Salem, North Carolina, United States, 27101
Completed
19
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Austin Epilepsy Care Center - Clinic/Outpatient Facility
Austin, Texas, United States, 78758
Completed
21
Neurology Consultants of Dallas, PA - Hospital
Dallas, Texas, United States, 75231
Completed
22
Virginia Epilepsy and Neurodevelopmental Clinic at WNC
Winchester, Virginia, United States, 22601
Completed
23
Hospital de Ninos de La Santisma Trinidad
Córdoba, Córdoba Province, Argentina
Completed
24
Resolution Psychopharmacology Research Institute
Mendoza, Mendoza Province, Argentina
Completed
25
Austin Hosptial
Heidelberg, Australia
Actively Recruiting
26
Alfred Health
Melbourne, Australia
Actively Recruiting
27
Perth's Children Hospital
Nedlands, Australia
Completed
28
Queensland Children's Hospital
South Brisbane, Australia
Completed
29
Fundacion Hospital Universidad del Norte
Barranquilla, Colombia
Withdrawn
30
Fundacion Valle del Lili/Clinic - Outpatient
Cali, Colombia
Withdrawn
31
CliniSalud del Sur S.A.S - Centro de Investigación
Envigado, Colombia
Completed
32
Hospital Pabloe Tubon Uribe
Medellín, Colombia
Completed
33
Institutio Neurologico de Colombia
Medellín, Colombia
Actively Recruiting
34
Universitatsklinikum Erangen
Erlangen, Bavaria, Germany
Actively Recruiting
35
Kleinwachau Sächsisches Epilepsiezentrum
Radeberg, Saxony, Germany
Actively Recruiting
36
Iaso Children's Hospital
Marousi, Attica, Greece
Actively Recruiting
37
Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet
Budapest, Hungary
Completed
38
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
Budapest, Hungary
Actively Recruiting
39
Tela Viv Sourlasky Medical Center
Tel Aviv, Tel Aviv, Israel
Completed
40
Soroka University Medical Centre
Beersheba, Israel
Completed
41
Hadassah Medical Center
Jerusalem, Israel, 91220
Completed
42
Sheba Medical Center
Ramat Gan, Israel
Completed
43
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, Italy
Actively Recruiting
44
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
Milan, Lombardy, Italy
Actively Recruiting
45
Fondazione IRCCS Di Rilievo Nazionale Instituto
Milan, Lombardy, Italy
Actively Recruiting
46
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Verona, Italy
Actively Recruiting
47
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Italy
Actively Recruiting
48
ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo
Milan, Italy
Completed
49
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Actively Recruiting
50
Neurociencias Estudios Clinicos S.C.
Culiacán, Mexico
Actively Recruiting
51
Clinstile, S.A. de C.V.
Mexico City, Mexico, 06700
Actively Recruiting
52
Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
Poznan, Greater Poland Voivodeship, Poland
Completed
53
Centrum Medyczne Plejady
Krakow, Poland
Actively Recruiting
54
Centro Hospitalar de Lisboa Norte, EPE
Lisbon, Lisbon District, Portugal
Actively Recruiting
55
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
Lisbon, Lisbon District, Portugal
Completed
56
Centro Hospitalar de Sao Joao, EPE
Porto, Porto District, Portugal
Actively Recruiting
57
Hospital Garcia de Orta
Almada, Setúbal District, Portugal
Completed
58
Childrens University Hospital
Belgrade, Belgrade, Serbia
Actively Recruiting
59
University Clinical Center of Serbia - PPDS
Belgrade, Serbia
Actively Recruiting
60
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
61
University Clinical Center Nis
Niš, Serbia
Actively Recruiting
62
Children and Youth Health Care Institute of Vojvodina
Novi Sad, Serbia
Actively Recruiting
63
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
64
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
65
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
66
Hospital Sant Joan de Deu - PIN
Esplugues de Llobregat, Barcelona, Spain
Completed
67
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Spain
Actively Recruiting
68
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Spain
Actively Recruiting
69
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
70
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
71
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Completed
Research Team
B
Barbara Remes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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