Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

PHASE3RecruitingINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

April 28, 2022

Primary Completion Date

February 28, 2027

Study Completion Date

December 31, 2028

Conditions
SeizuresLennox Gastaut Syndrome
Interventions
DRUG

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 \[or a total of 600 mg per day\])."

Trial Locations (71)

10467

COMPLETED

Montefiore, The Bronx

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20817

RECRUITING

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

22601

COMPLETED

Virginia Epilepsy and Neurodevelopmental Clinic at WNC, Winchester

27101

COMPLETED

Wake Forest University - School of Medicine, Winston-Salem

27713

RECRUITING

Duke University Clinical Research at Pickett Road, Durham

32209

COMPLETED

University of Florida Health Science Center, Jacksonville

32803

COMPLETED

AdventHealth, Orlando

33414

COMPLETED

Axcess Medical Research, Wellington

33609

RECRUITING

Pediatric Epilepsy and Neurology Specialists, Tampa

33620

COMPLETED

University of South Florida, Tampa

40504

COMPLETED

Bluegrass Epilepsy Research, LLC, Lexington

55905

COMPLETED

Mayo Clinic, Rochester

65211

COMPLETED

University of Missouri School of Medicine, Columbia

70112

COMPLETED

University Medical Center New Orleans, New Orleans

75231

COMPLETED

Neurology Consultants of Dallas, PA - Hospital, Dallas

78758

COMPLETED

Austin Epilepsy Care Center - Clinic/Outpatient Facility, Austin

83702

COMPLETED

Consultants in Epilepsy and Neurology PLLC, Boise

91220

COMPLETED

Hadassah Medical Center, Jerusalem

94305

RECRUITING

Stanford University Hospital, Palo Alto

07601

RECRUITING

Northeast Regional Epilepsy Group, Hackensack

08901

COMPLETED

St. Peters Hospital, New Brunswick

Unknown

COMPLETED

Hospital de Ninos de La Santisma Trinidad, Córdoba

COMPLETED

Resolution Psychopharmacology Research Institute, Mendoza

RECRUITING

Austin Hosptial, Heidelberg

RECRUITING

Alfred Health, Melbourne

COMPLETED

Perth's Children Hospital, Nedlands

COMPLETED

Queensland Children's Hospital, South Brisbane

WITHDRAWN

Fundacion Hospital Universidad del Norte, Barranquilla

COMPLETED

CliniSalud del Sur S.A.S - Centro de Investigación, Envigado

COMPLETED

Hospital Pabloe Tubon Uribe, Medellín

RECRUITING

Institutio Neurologico de Colombia, Medellín

WITHDRAWN

Fundacion Valle del Lili/Clinic - Outpatient, Santiago de Cali

RECRUITING

Universitatsklinikum Erangen, Erlangen

RECRUITING

Kleinwachau Sächsisches Epilepsiezentrum, Radeberg

RECRUITING

Iaso Children's Hospital, Marousi

COMPLETED

Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet, Budapest

RECRUITING

Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika, Budapest

COMPLETED

Tela Viv Sourlasky Medical Center, Tel Aviv

COMPLETED

Soroka University Medical Centre, Beersheba

COMPLETED

Sheba Medical Center, Ramat Gan

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN, Genoa

RECRUITING

ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi, Milan

RECRUITING

Fondazione IRCCS Di Rilievo Nazionale Instituto, Milan

RECRUITING

Azienda Ospedaliera Universitaria Integrata Di Verona, Verona

RECRUITING

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN, Florence

COMPLETED

ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo, Milan

RECRUITING

Hospital Civil Fray Antonio Alcalde, Guadalajara

RECRUITING

Neurociencias Estudios Clinicos S.C., Culiacán

COMPLETED

Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2, Poznan

RECRUITING

Centrum Medyczne Plejady, Krakow

RECRUITING

Centro Hospitalar de Lisboa Norte, EPE, Lisbon

COMPLETED

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier, Lisbon

RECRUITING

Centro Hospitalar de Sao Joao, EPE, Porto

COMPLETED

Hospital Garcia de Orta, Almada

RECRUITING

Childrens University Hospital, Belgrade

RECRUITING

University Clinical Center of Serbia - PPDS, Belgrade

RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

University Clinical Center Nis, Niš

RECRUITING

Children and Youth Health Care Institute of Vojvodina, Novi Sad

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Hospital, Seoul

COMPLETED

Hospital Sant Joan de Deu - PIN, Esplugues de Llobregat

RECRUITING

Hospital Infantil Universitario Niño Jesus - PIN, Madrid

RECRUITING

Hospital Ruber Internacional (Grupo Quironsalud), Madrid

RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Taipei Veterans General Hospital, Taipei

COMPLETED

Chang Gung Memorial Hospital, Taoyuan District

06700

RECRUITING

Clinstile, S.A. de C.V., Mexico City

All Listed Sponsors
lead

SK Life Science, Inc.

INDUSTRY