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

Primary Purpose

Seizures, Lennox Gastaut Syndrome

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carisbamate
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring Seizures, Lennox Gastaut Syndrome, Pediatrics, Adults

Eligibility Criteria

4 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

    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) each week during the 4-week Baseline period preceding randomization. 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. For seizures that occur in clusters: if countable, an exact seizure count should be used; if uncountable, the caregiver should estimate the number of seizures.
  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 parent(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:

  1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
  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 of Visit 1
  9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as determined 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.

Sites / Locations

  • Stanford University HospitalRecruiting
  • University of Florida Health Science CenterRecruiting
  • Pediatric Epilepsy and Neurology SpecialistsRecruiting
  • University of South FloridaRecruiting
  • Axcess Medical ResearchRecruiting
  • Consultants in Epilepsy and Neurology PLLCRecruiting
  • Bluegrass Epilepsy Research, LLCRecruiting
  • University Medical Center New OrleansRecruiting
  • Johns Hopkins HospitalRecruiting
  • Mid-Atlantic Epilepsy and Sleep CenterRecruiting
  • Mayo ClinicRecruiting
  • University of Missouri School of MedicineRecruiting
  • Northeast Regional Epilepsy GroupRecruiting
  • St. Peters HospitalRecruiting
  • MontefioreRecruiting
  • Duke University Clinical Research at Pickett RoadRecruiting
  • Wake Forest University - School of MedicineRecruiting
  • Austin Epilepsy Care Center - Clinic/Outpatient FacilityRecruiting
  • Neurology Consultants of Dallas, PA - HospitalRecruiting
  • Virginia Epilepsy and Neurodevelopmental Clinic at WNCRecruiting
  • Hospital de Ninos de La Santisma TrinidadRecruiting
  • Resolution Psychopharmacology Research InstituteRecruiting
  • Fundacion Hospital Universidad del Norte
  • Fundacion Valle del Lili/Clinic - Outpatient
  • CliniSalud del Sur S.A.S - Centro de InvestigaciónRecruiting
  • Hospital Pabloe Tubon Uribe
  • Institutio Neurologico de ColombiaRecruiting
  • Universitatsklinikum ErangenRecruiting
  • Kleinwachau Sächsisches EpilepsiezentrumRecruiting
  • Iaso Children's HospitalRecruiting
  • Tela Viv Sourlasky Medical CenterRecruiting
  • Soroka University Medical CentreRecruiting
  • Hadassah Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PINRecruiting
  • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore BuzziRecruiting
  • Fondazione IRCCS Di Rilievo Nazionale InstitutoRecruiting
  • Azienda Ospedaliera Universitaria Integrata Di VeronaRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Hospital Civil Fray Antonio AlcaldeRecruiting
  • Neurociencias Estudios Clinicos S.C.Recruiting
  • Clinstile, S.A. de C.V.Recruiting
  • Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2Recruiting
  • Centrum Medyczne PlejadyRecruiting
  • Hospital Garcia de OrtaRecruiting
  • Centro Hospitalar de Lisboa Norte, EPERecruiting
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco XavierRecruiting
  • Centro Hospitalar de Sao Joao, EPERecruiting
  • Childrens University HospitalRecruiting
  • University Clinical Center KragujevacRecruiting
  • University Clinical Center NisRecruiting
  • Hospital Sant Joan de Deu - PINRecruiting
  • Hospital Infantil Universitario Niño Jesus - PINRecruiting
  • Hospital Ruber Internacional (Grupo Quironsalud)Recruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Carisbamate 200 mg BID arm

Carisbamate 300 mg BID arm

Placebo matched to 200 mg BID arm

Placebo matched to 300 mg BID arm

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Efficacy of Carisbamate YKP509

Secondary Outcome Measures

The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.
Efficacy of Carisbamate YKP509
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.
Efficacy of Carisbamate YKP509
Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.
Efficacy of Carisbamate YKP509- Scoring will be from 1 to 7 with 1 (very much improved) to 7 (very much worse)

Full Information

First Posted
January 6, 2022
Last Updated
September 11, 2023
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05219617
Brief Title
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
The secondary objectives are: 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) Assess subject's Quality of Life (QOL) Evaluate the safety, tolerability of carisbamate in the LGS population Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Lennox Gastaut Syndrome
Keywords
Seizures, Lennox Gastaut Syndrome, Pediatrics, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This double-blind, randomized, placebo-controlled study will evaluate the efficacy of carisbamate 200 mg BID or the pediatric equivalent dose and 300 mg BID or the pediatric equivalent dose for the treatment of seizures associated with Lennox Gastaut syndrome in subjects 4 to 55 years of age.
Masking
ParticipantCare Provider
Masking Description
Double-blind study
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carisbamate 200 mg BID arm
Arm Type
Experimental
Arm Description
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
Arm Title
Carisbamate 300 mg BID arm
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo matched to 200 mg BID arm
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Placebo matched to 300 mg BID arm
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Carisbamate
Intervention Description
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 (not to exceed 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 (not to exceed a total of 600 mg per day).
Primary Outcome Measure Information:
Title
Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.
Description
Efficacy of Carisbamate YKP509- Scoring will be from 1 to 7 with 1 (very much improved) to 7 (very much worse)
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the maintenance phase of the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
5. Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the maintenance phase of the double-blind treatment period.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years
Title
Quality of Life (QOL) based on standardized measures such as: Vineland & BRIEF Scale, for pediatric and adult subjects, when able to be assessed and only in English.
Description
Efficacy of Carisbamate YKP509
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) each week during the 4-week Baseline period preceding randomization. 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. For seizures that occur in clusters: if countable, an exact seizure count should be used; if uncountable, the caregiver should estimate the number of seizures. 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 parent(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 Exclusion Criteria: Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor 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 Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling Current use of felbamate with less than 18 months of continuous exposure 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. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline Status epilepticus within 12 weeks of Visit 1 Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as determined by the Investigator Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2) 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 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. Subject is pregnant, may be pregnant, lactating or planning to be pregnant 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 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. 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 Subject with total bilirubin [TBL] >2 x ULN (except for Gilbert's syndrome). Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1) History of positive antibody/antigen test for human immunodeficiency virus (HIV) If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1) 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 Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG) Benzodiazepine rescue administered on average more than once a week in the month before Visit 1 Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Remes
Phone
201-421-3810
Email
bremes@sklsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kamin, MD
Organizational Affiliation
SK Life Science, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Porter, MD
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Bautista, MD
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Ferreira, MD
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salim Benbadis, MD
Facility Name
Axcess Medical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Flasterstein, MD
Facility Name
Consultants in Epilepsy and Neurology PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Wechsler, MD
Facility Name
Bluegrass Epilepsy Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toufic Fakhoury, MD
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Olejniczak, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Yi Kang, MD
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arkady Barber
First Name & Middle Initial & Last Name & Degree
Pavel Klein, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Wirrell, MD
Facility Name
University of Missouri School of Medicine
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Carney, MD
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Segal, MD
Facility Name
St. Peters Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Lastra, MD
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Boro, MD
Facility Name
Duke University Clinical Research at Pickett Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Zafar, MD
Facility Name
Wake Forest University - School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautam Popli, MD
Facility Name
Austin Epilepsy Care Center - Clinic/Outpatient Facility
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Mohamad Aboumatar, MD
Facility Name
Neurology Consultants of Dallas, PA - Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fonda Chan, MD
Facility Name
Virginia Epilepsy and Neurodevelopmental Clinic at WNC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Lyons
Facility Name
Hospital de Ninos de La Santisma Trinidad
City
Córdoba
State/Province
Cordoba
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Ariel Martinez, MD
Facility Name
Resolution Psychopharmacology Research Institute
City
Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Velasco, MD
Facility Name
Fundacion Hospital Universidad del Norte
City
Barranquilla
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Aguilera
First Name & Middle Initial & Last Name & Degree
Lilia Sanchez Anquilar
Facility Name
Fundacion Valle del Lili/Clinic - Outpatient
City
Cali
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Revelo Castro
First Name & Middle Initial & Last Name & Degree
Juan Fernando Gomez Castro
Facility Name
CliniSalud del Sur S.A.S - Centro de Investigación
City
Envigado
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orlando Carreno
Facility Name
Hospital Pabloe Tubon Uribe
City
Medellín
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Camacho Orondez
Facility Name
Institutio Neurologico de Colombia
City
Medellín
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jiminez, MD
Facility Name
Universitatsklinikum Erangen
City
Erlangen
State/Province
Bayern
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajo Martinus Hamer, MD
Facility Name
Kleinwachau Sächsisches Epilepsiezentrum
City
Radeberg
State/Province
Sachsen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Holert, MD
Facility Name
Iaso Children's Hospital
City
Maroúsi
State/Province
Attiki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antigoni Papavasileiou, MD
Facility Name
Tela Viv Sourlasky Medical Center
City
Tel Aviv Yafo
State/Province
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimrit Uliel-Syboni, MD
Facility Name
Soroka University Medical Centre
City
Be'er Sheva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Noyman, MD
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91220
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tal Gilboa, MD
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruria Ben Zeev, MD
Facility Name
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
City
Genova
State/Province
Liguria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Striano, MD
Facility Name
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
City
Milano
State/Province
Lombardia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Lodi, MD
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Instituto
City
Milano
State/Province
Lombardia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Freri, MD
Facility Name
Azienda Ospedaliera Universitaria Integrata Di Verona
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Darra, MD
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soonhak Kwon, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Hun S. Lee, MD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung Chan Lim, MD
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Ceja Moreno, MD
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacán
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elmer Lopez Meza, MD
Facility Name
Clinstile, S.A. de C.V.
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Quinones, MD
Facility Name
Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
City
Poznan
State/Province
Wielkopolskie
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Steinborn, MD
Facility Name
Centrum Medyczne Plejady
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Zolnowska, MD
Facility Name
Hospital Garcia de Orta
City
Almada
State/Province
Setubal
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Paulo Monteiro, MD
Facility Name
Centro Hospitalar de Lisboa Norte, EPE
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Quintas, MD
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Carlos Ferreira, MD
Facility Name
Centro Hospitalar de Sao Joao, EPE
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Sousa, MD
Facility Name
Childrens University Hospital
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrije Nikolic, MD
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandar Gavrilovic, MD
Facility Name
University Clinical Center Nis
City
Niš
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Tosic, MD
Facility Name
Hospital Sant Joan de Deu - PIN
City
Esplugues De Llobregat
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Aparicio Calvo, MD
Facility Name
Hospital Infantil Universitario Niño Jesus - PIN
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Soto Insuga, MD
Facility Name
Hospital Ruber Internacional (Grupo Quironsalud)
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Gil-Nigel, MD
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang-Tso Lee, MD
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting-Rong Hsu, MD
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Li Wu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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