A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension

Who is this study for? Patients with Seizures, Lennox Gastaut Syndrome
What treatments are being studied? Carisbamate
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 55
Healthy Volunteers: f
View:

• Subject must have a documented history of Lennox-Gastaut syndrome by:

∙ Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure

‣ History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \<3.0 Hz)

‣ History of developmental delay

• Male or female subjects

• Subjects must be age 4-55 years at the time of consent/assent

• Must have been \<11 years old at the onset of LGS

• 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).

• 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

• 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.

• 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.

• Parents or caregivers must be able to keep accurate seizure diaries

⁃ 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.

⁃ Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study

⁃ Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements

⁃ History of COVID-19 vaccination is permitted

Locations
United States
California
Stanford University Hospital
RECRUITING
Palo Alto
Florida
University of Florida Health Science Center
COMPLETED
Jacksonville
AdventHealth
COMPLETED
Orlando
Pediatric Epilepsy and Neurology Specialists
RECRUITING
Tampa
University of South Florida
COMPLETED
Tampa
Axcess Medical Research
COMPLETED
Wellington
Idaho
Consultants in Epilepsy and Neurology PLLC
COMPLETED
Boise
Kentucky
Bluegrass Epilepsy Research, LLC
COMPLETED
Lexington
Louisiana
University Medical Center New Orleans
COMPLETED
New Orleans
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Mid-Atlantic Epilepsy and Sleep Center
RECRUITING
Bethesda
Minnesota
Mayo Clinic
COMPLETED
Rochester
Missouri
University of Missouri School of Medicine
COMPLETED
Columbia
North Carolina
Duke University Clinical Research at Pickett Road
RECRUITING
Durham
Wake Forest University - School of Medicine
COMPLETED
Winston-salem
New Jersey
Northeast Regional Epilepsy Group
RECRUITING
Hackensack
St. Peters Hospital
COMPLETED
New Brunswick
New York
Montefiore
COMPLETED
The Bronx
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Austin Epilepsy Care Center - Clinic/Outpatient Facility
COMPLETED
Austin
Neurology Consultants of Dallas, PA - Hospital
COMPLETED
Dallas
Virginia
Virginia Epilepsy and Neurodevelopmental Clinic at WNC
COMPLETED
Winchester
Other Locations
Argentina
Hospital de Ninos de La Santisma Trinidad
COMPLETED
Córdoba
Resolution Psychopharmacology Research Institute
COMPLETED
Mendoza
Australia
Austin Hosptial
RECRUITING
Heidelberg
Alfred Health
RECRUITING
Melbourne
Perth's Children Hospital
COMPLETED
Nedlands
Queensland Children's Hospital
COMPLETED
South Brisbane
Colombia
Fundacion Hospital Universidad del Norte
WITHDRAWN
Barranquilla
CliniSalud del Sur S.A.S - Centro de Investigación
COMPLETED
Envigado
Hospital Pabloe Tubon Uribe
COMPLETED
Medellín
Institutio Neurologico de Colombia
RECRUITING
Medellín
Fundacion Valle del Lili/Clinic - Outpatient
WITHDRAWN
Santiago De Cali
Germany
Universitatsklinikum Erangen
RECRUITING
Erlangen
Kleinwachau Sächsisches Epilepsiezentrum
RECRUITING
Radeberg
Greece
Iaso Children's Hospital
RECRUITING
Marousi
Hungary
Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet
COMPLETED
Budapest
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
RECRUITING
Budapest
Israel
Soroka University Medical Centre
COMPLETED
Beersheba
Hadassah Medical Center
COMPLETED
Jerusalem
Sheba Medical Center
COMPLETED
Ramat Gan
Tela Viv Sourlasky Medical Center
COMPLETED
Tel Aviv
Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
RECRUITING
Florence
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
RECRUITING
Genoa
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
RECRUITING
Milan
ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo
COMPLETED
Milan
Fondazione IRCCS Di Rilievo Nazionale Instituto
RECRUITING
Milan
Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITING
Verona
Mexico
Neurociencias Estudios Clinicos S.C.
RECRUITING
Culiacán
Hospital Civil Fray Antonio Alcalde
RECRUITING
Guadalajara
Clinstile, S.A. de C.V.
RECRUITING
Mexico City
Poland
Centrum Medyczne Plejady
RECRUITING
Krakow
Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
COMPLETED
Poznan
Portugal
Hospital Garcia de Orta
COMPLETED
Almada
Centro Hospitalar de Lisboa Norte, EPE
RECRUITING
Lisbon
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
COMPLETED
Lisbon
Centro Hospitalar de Sao Joao, EPE
RECRUITING
Porto
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Serbia
Childrens University Hospital
RECRUITING
Belgrade
University Clinical Center of Serbia - PPDS
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Nis
RECRUITING
Niš
Children and Youth Health Care Institute of Vojvodina
RECRUITING
Novi Sad
Spain
Hospital Sant Joan de Deu - PIN
COMPLETED
Esplugues De Llobregat
Hospital Infantil Universitario Niño Jesus - PIN
RECRUITING
Madrid
Hospital Ruber Internacional (Grupo Quironsalud)
RECRUITING
Madrid
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital
COMPLETED
Taoyuan District
Contact Information
Primary
Barbara Remes
bremes@sklsi.com
201-421-3810
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2028-12
Participants
Target number of participants: 252
Treatments
Experimental: 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
Experimental: 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
Placebo_comparator: 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
Placebo_comparator: 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
Sponsors
Leads: SK Life Science, Inc.

This content was sourced from clinicaltrials.gov