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Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

Primary Purpose

Primary Generalized Epilepsy

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

About this trial

This is an interventional treatment trial for Primary Generalized Epilepsy focused on measuring Primary Generalized Tonic-Clonic Seizures, PGTC, Idiopathic Generalized Epilepsy, Generalized Tonic-Clonic Seizures

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is male or female and aged ≥12 years.
  2. Written informed consent signed by the subject or legal guardian, or legally authorized representative (LAR), prior to entering the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Age- appropriate assent will be obtained for adolescents. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the Informed Consent Form (ICF) in accordance with ICH guidelines.
  3. Female subjects of childbearing potential are willing to use an acceptable form of birth control
  4. Subject has a clinical diagnosis of PGTC seizures (with or without other subtypes of generalized seizures) in the setting of idiopathic generalized epilepsy.
  5. Subject experiences at least 5 PGTC seizures in 12 weeks during the Pre-Randomization Period.
  6. Subject has had a routine electroencephalogram (EEG) within 5 years prior to Visit1 (Screening/Baseline) or during the Pre-Randomization Period with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history.
  7. Subject has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to Visit 1 (Screening/Baseline) or during the Pre-Randomization Period that ruled out a progressive cause of epilepsy.
  8. Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens for a minimum of 30 days prior to Visit 1 (Screening/Baseline).

    1. Benzodiazepines (except diazepam, see Exclusion Criterion No.7) taken at least once per week during the 30 days prior to Visit 1 (Screening/Baseline) for epilepsy, anxiety, or sleep disorder will be counted as 1 AED and the dosage must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed. (See Exclusion Criterion No. 10 for intermittent benzodiazepine rescue parameters.)
    2. Subjects receiving felbamate as a concomitant AED must meet the following criteria: i. Have a 2-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening/Baseline). ii. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.
  9. Subject with an implanted vagal nerve or deep brain stimulator will be allowed if the stimulator was implanted at least 5 months prior to Visit 1 (Screening/Baseline) and the stimulator parameters are not changed for 30 days prior to Visit 1 and for the duration of the study.
  10. Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 (Screening/Baseline) and will remain stable for the duration of the study.

Exclusion Criteria:

  1. Female subjects who are pregnant (or planning to become pregnant during the study), lactating, or breast-feeding.
  2. Subject has a history o f status epilepticus that required hospitalization within 12 months prior to Visit 1 (Screening/Baseline).
  3. Subject has PGTC seizure clusters where individual seizures cannot be counted or classified.
  4. Subject has a history of non-epileptic psychogenic seizures.
  5. Subject has a concomitant diagnosis of Partial Onset Seizures (POS).
  6. Subject has a clinical diagnosis of Lennox-Gastaut syndrome.
  7. Subject is currently taking (within the 30 days prior to Visit 1 [Screening/Baseline]) any of the following medications: diazepam (for any reason other than as intermittent benzodiazepine rescue medication), phenytoin, mephenytoin, fosphenytoin, phenobarbital, primidone, ethotoin, clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, or efavirenz.
  8. Subject has participated in previous cenobamate clinical studies.
  9. Subject has a history of vigabatrin use within 5months prior to Visit 1 (Screening/Baseline), or the subject plans to begin treatment with vigabatrin during the study.

    a) A subject with a history of vigabatrin use that ended more than 5 months prior to Visit1 may be enrolled after documented evidence of no vigabatrin-associated clinically significant abnormality in an automated visual perimetry test.

  10. Subject has a history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) 4 or more times within the 30 days prior to Visit 1 (Screening/Baseline).
  11. Subject has received an investigational drug or device within 30 days prior to Visit 1 (Screening/Baseline).
  12. Subject has a history of drug or alcohol dependency or abuse within 2 years prior to Visit 1 (Screening/Baseline).
  13. Subject tests positive, via urine drug screen at Visit 1 (Screening/Baseline), for illicit drugs not legalized in your region/state, or for a drug that has not been prescribed (e.g., certain opiates).
  14. Subject has a history of any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization.
  15. History of AED-associated rash that involved conjunctiva or mucosae.
  16. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication.
  17. Subject has evidence of clinically significant abnormalities or disease (e.g., psychiatric, cardiac, respiratory, gastrointestinal, hepatic [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal (ULN), or total or direct bilirubin not more than ULN], or renal disease) that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.
  18. Presence of congenital short QT syndrome or relevant replicated change in QT/QTc interval less than 340 msec on ECG.
  19. Subject has any significant active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
  20. Subject has a creatinine clearance less than 50 mL/min, as calculated by Cockcroft-Gault equation.
  21. Subject has an absolute neutrophil count less than 1500/µL.
  22. Subject has platelet count lower than 80,000/µL in subjects treated with valproate.
  23. Subject has a history of positive antibody/antigen test for hepatitis A, hepatitis B, hepatitis C, or HIV.
  24. Subject has any suicidal ideation (with intent with or without a plan) at Visit 1 (Screening/Baseline) or Visit 4 (Randomization) (i.e., answering YES to Question 4 and/or Question 5 on the Suicidal Ideation section of the C-SSRS).
  25. Subject has more than 1 lifetime suicide attempt.
  26. Subject is a staff member or immediate family member of study staff.
  27. Previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension.

Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor.

Sites / Locations

  • Neuro Pain Medical Center
  • Colorado Springs Neurological Associates
  • Children's Hospital of ColoradoRecruiting
  • Brainstorm Research
  • Florida Hospital Medical Group
  • University of South FloridaRecruiting
  • Hawaii Pacific Neuroscience
  • Consultants in Epilepsy and Neurology
  • Rush UniversityRecruiting
  • Indiana University
  • PMG Research of McFarland Clinic
  • University of Kentucky
  • Maine Medical Center
  • Mid-Atlantic Epilepsy and Sleep CenterRecruiting
  • Michigan State University
  • Minneapolis Clinic of Neurology Golden ValleyRecruiting
  • University of Missouri Health CareRecruiting
  • JFK Medical Center- The Neuroscience Institute
  • Northeast Regional Epilepsy GroupRecruiting
  • New York Presbyterian Hospital
  • UBMD Neurology
  • Five Towns Neuroscience Research
  • Duke University Children's Health CenterRecruiting
  • Ohio Health Research and Innovation Institute
  • University of ToledoRecruiting
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University
  • Temple University Lewis Katz School of Medicine
  • LeBonheur Children's Medical CenterRecruiting
  • Vanderbilt University Medical Center
  • Child Neurology Consultants of AustinRecruiting
  • ANRC ResearchRecruiting
  • Baylor College of Medicine
  • Carilion Clinic
  • Valley Medical Center
  • MultiCare Institute for Research and Innovation
  • Children's Health Queensland HospitalRecruiting
  • MHAT Sv. Ivan Rilski Gorna Oryahovitsa EOOD
  • Multiprofile Hospital for Active Treatment Puls AD
  • UMHAT Kanev AD
  • MHAT Lyulin EAD
  • Acibadem City Clinic MHAT Tokuda EAD
  • Diagnostic Consultative Center Neoclinic EAD
  • Diagnostic Consultative Center Equita EOOD
  • Medical Center Medica Plus OOD
  • Fakultní nemocnice v Motole
  • Fakultni nemocnice u sv. Anny v Brne, 1. Neurologicka klinika
  • Nestatni zdravotnicke zarizeni, privatni ordinance neurologie
  • Cerebrovaskularni poradna, s.r.o.
  • Cerebovaskularni poradna s.r.o.
  • Forbeli s.r.o., Neurologicka ordinace
  • Vestra Clinics, s.r.o.
  • Neurologicka ambulance MUDr.Monika Zahumenska
  • Charite - Universitätsmedizin Berlin - Sozialpädiatrisches ZentrumRecruiting
  • Universitätsklinikum JenaRecruiting
  • Sächsisches Epilepsiezentrum Kleinwachau gGmbHRecruiting
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Klinikai Központ, Gyermekgyógyászati Intézet Nagyerdei krt. 98Recruiting
  • Csongrád Megyei Egészségügyi Elláto Központ Ideggyógyászati Osztály
  • Chungbuk National University HospitalRecruiting
  • CHA Bundang Medical CenterRecruiting
  • SMG-SNU Boramae Medical CenterRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Ajou University HospitalRecruiting
  • NZOZ Poradnia Zdrowia Psychicznego Antonijczuk Boleslaw
  • Centrum Medyczne Oporów
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
  • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
  • Centrum Medyczne PlejadyRecruiting
  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. sw. Ludwika sw KrakowieRecruiting
  • Centrum Leczenia Padaczki i Migreny
  • Centrum Medyczne Warszawa Pratia s.a
  • Gornoslaskie Centrum Medyczne - Samodzielny Publiczny Szpital Kliniczny Number 7
  • Centrum Medyczne Pratia Katowice
  • M.A. LEK A.M. Maciejowscy S.C Centrum Terapii SM
  • Niepubliczny Zaklad Opieki Zdrowotnej Novo-Med
  • Gyncentrum Clinic Sp. z.o.o
  • Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia PadaczkiRecruiting
  • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R sp. k
  • Konzílium, s.r.oRecruiting
  • MUDr. Beata Dupejova, neurologická ambulncia, s.r.o
  • IN MEDIC s.r.oRecruiting
  • Narodny Ustav Detskych ChorobRecruiting
  • MEDBAJ, s.r.o., Neurologicka ambulancia, Nemocnicna 1944/10
  • NEURES, s.r.o.-Neurologická Ambulancia
  • Hospital Clínico San CarlosRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario La Fe
  • Municipal Non-profit Enterprise City Clinical Hospital No.16 of Dnipro City Council, Department of Neurology
  • Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Regional Center of Psychosomatic Disorders based on Psychoneurology Department
  • Kyiv City Psychoneurological Hospital №2
  • Municipal Non-Profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of Cerebro-Vascular Diseases with Neurosurgery
  • Municipal Non-profit Enterprise Regional Clinical Center of Neurosurgery and Neurology of Zakarpattia Regional Council, Department of Neurosurgery #2
  • Municipal Non-Profit Enterprise Zaporizhzhia Regional Clinical Hospital Of Zaporizhzhia Regional Council
  • Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council
  • Municipal Non-profit Enterprise Prykarpattia Regional Clinical Center for Mental Health of Ivano-Frankivsk Regional Council
  • Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional Clinical Psychiatric Hospital #3
  • Communal Non-Profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Neurological Department, Antiepileptic Center
  • Communal Non-Profit Enterprise Odesa Regional Medical Centre of Mental Health Odesa Regional Council, Department #2
  • Odessa Regional Psychiatric Hospital No. 2,
  • Communal Enterprise Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev of Poltava Regional Council
  • Municipal Non-Profit Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Neurology #2
  • Municipal Non-profit Enterprise Vinnytsia Regional Clinical Psychoneurological Hospital named after Acad. O.I. Yushchenko of Vinnytsia Regional Council, Department of Neurology #3

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cenobamate

Placebo

Arm Description

Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.

Matching placebo

Outcomes

Primary Outcome Measures

Seizure Diary
Daily seizure diary that contains type and frequency of seizures

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
October 20, 2023
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03678753
Brief Title
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With PGTC Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
June 19, 2024 (Anticipated)
Study Completion Date
July 19, 2024 (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
This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study.
Detailed Description
This randomized, double-blind, placebo controlled trial is designed to evaluate safety, efficacy, and pharmacokinetics of cenobamate adjunctive therapy as compared to placebo on PGTC seizures in subject with idiopathic generalized epilepsy. Subjects will be randomized to receive either cenobamate or placebo on a 1:1 basis. The study will have three periods, pre-randomization period where a baseline seizure frequency is established, treatment period and follow up period. The treatment period consists of a 10 week titration phase where subjects are titrated slowly until they reach the target dose and a maintenance phase. During the titration phase, subjects will receive 12.5 mg study drug, followed by 25 mg, 50 mg, 100 mg, and 150 mg study drug every two weeks. During the maintenance phase, subjects will receive the target dose of 200 mg study drug or adolescent equivalent. Subjects will take their once daily dose of study drug at approximately the same in the morning with or without food. If tolerability issues arise, subjects can switch to evening dosing. There is also an option to down-titrate to 150 mg study drug, one time only. If tolerability issues continue, subjects may be discontinued. Upon completion of the maintenance phase, eligible subjects will have an opportunity to enroll in an open-label safety study. Subjects who discontinue early or do not wish to participate in this additional study will complete the three week follow up period. Subjects may receive a one week down titration to 100 mg and return for a follow up visit 2 weeks later. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight. Throughout the study, subjects will keep a diary containing the type and frequency of seizures. This will be the primary efficacy measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Generalized Epilepsy
Keywords
Primary Generalized Tonic-Clonic Seizures, PGTC, Idiopathic Generalized Epilepsy, Generalized Tonic-Clonic Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cenobamate
Arm Type
Experimental
Arm Description
Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Cenobamate
Other Intervention Name(s)
YKP3089
Intervention Description
12.5 mg tablet, 25 mg tablet, 50 mg tablet, 100 mg tablets, 150 mg tablets, 200 mg tablets. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Seizure Diary
Description
Daily seizure diary that contains type and frequency of seizures
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is male or female and aged ≥12 years. Written informed consent signed by the subject or legal guardian, or legally authorized representative (LAR), prior to entering the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Age- appropriate assent will be obtained for adolescents. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the Informed Consent Form (ICF) in accordance with ICH guidelines. Female subjects of childbearing potential are willing to use an acceptable form of birth control Subject has a clinical diagnosis of PGTC seizures (with or without other subtypes of generalized seizures) in the setting of idiopathic generalized epilepsy. Subject experiences at least 5 PGTC seizures in 12 weeks during the Pre-Randomization Period. Subject has had a routine electroencephalogram (EEG) within 5 years prior to Visit1 (Screening/Baseline) or during the Pre-Randomization Period with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history. Subject has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to Visit 1 (Screening/Baseline) or during the Pre-Randomization Period that ruled out a progressive cause of epilepsy. Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens for a minimum of 30 days prior to Visit 1 (Screening/Baseline). Benzodiazepines (except diazepam, see Exclusion Criterion No.7) taken at least once per week during the 30 days prior to Visit 1 (Screening/Baseline) for epilepsy, anxiety, or sleep disorder will be counted as 1 AED and the dosage must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed. (See Exclusion Criterion No. 10 for intermittent benzodiazepine rescue parameters.) Subjects receiving felbamate as a concomitant AED must meet the following criteria: i. Have a 2-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening/Baseline). ii. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate. Subject with an implanted vagal nerve or deep brain stimulator will be allowed if the stimulator was implanted at least 5 months prior to Visit 1 (Screening/Baseline) and the stimulator parameters are not changed for 30 days prior to Visit 1 and for the duration of the study. Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 (Screening/Baseline) and will remain stable for the duration of the study. Exclusion Criteria: Female subjects who are pregnant (or planning to become pregnant during the study), lactating, or breast-feeding. Subject has a history o f status epilepticus that required hospitalization within 12 months prior to Visit 1 (Screening/Baseline). Subject has PGTC seizure clusters where individual seizures cannot be counted or classified. Subject has a history of non-epileptic psychogenic seizures. Subject has a concomitant diagnosis of Partial Onset Seizures (POS). Subject has a clinical diagnosis of Lennox-Gastaut syndrome. Subject is currently taking (within the 30 days prior to Visit 1 [Screening/Baseline]) any of the following medications: diazepam (for any reason other than as intermittent benzodiazepine rescue medication), phenytoin, mephenytoin, fosphenytoin, phenobarbital, primidone, ethotoin, clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, or efavirenz. Subject has participated in previous cenobamate clinical studies. Subject has a history of vigabatrin use within 5months prior to Visit 1 (Screening/Baseline), or the subject plans to begin treatment with vigabatrin during the study. a) A subject with a history of vigabatrin use that ended more than 5 months prior to Visit1 may be enrolled after documented evidence of no vigabatrin-associated clinically significant abnormality in an automated visual perimetry test. Subject has a history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) 4 or more times within the 30 days prior to Visit 1 (Screening/Baseline). Subject has received an investigational drug or device within 30 days prior to Visit 1 (Screening/Baseline). Subject has a history of drug or alcohol dependency or abuse within 2 years prior to Visit 1 (Screening/Baseline). Subject tests positive, via urine drug screen at Visit 1 (Screening/Baseline), for illicit drugs not legalized in your region/state, or for a drug that has not been prescribed (e.g., certain opiates). Subject has a history of any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization. History of AED-associated rash that involved conjunctiva or mucosae. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication. Subject has evidence of clinically significant abnormalities or disease (e.g., psychiatric, cardiac, respiratory, gastrointestinal, hepatic [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal (ULN), or total or direct bilirubin not more than ULN], or renal disease) that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study. Presence of congenital short QT syndrome or relevant replicated change in QT/QTc interval less than 340 msec on ECG. Subject has any significant active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results. Subject has a creatinine clearance less than 50 mL/min, as calculated by Cockcroft-Gault equation. Subject has an absolute neutrophil count less than 1500/µL. Subject has platelet count lower than 80,000/µL in subjects treated with valproate. Subject has a history of positive antibody/antigen test for hepatitis A, hepatitis B, hepatitis C, or HIV. Subject has any suicidal ideation (with intent with or without a plan) at Visit 1 (Screening/Baseline) or Visit 4 (Randomization) (i.e., answering YES to Question 4 and/or Question 5 on the Suicidal Ideation section of the C-SSRS). Subject has more than 1 lifetime suicide attempt. Subject is a staff member or immediate family member of study staff. Previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension. Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunita Misra, MD
Phone
1-402-835-5977
Email
smisra@sklsi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deena Peace
Phone
1-401-206-4078
Email
dpeace@sklsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Misra, MD
Organizational Affiliation
SK Life Science, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Neuro Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Completed
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Colorado
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Completed
Facility Name
Florida Hospital Medical Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Completed
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Completed
Facility Name
Consultants in Epilepsy and Neurology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Completed
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Completed
Facility Name
PMG Research of McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Completed
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Completed
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Completed
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 Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Completed
Facility Name
Minneapolis Clinic of Neurology Golden Valley
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
JFK Medical Center- The Neuroscience Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Individual Site Status
Completed
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Presbyterian Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Completed
Facility Name
UBMD Neurology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Completed
Facility Name
Five Towns Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Individual Site Status
Completed
Facility Name
Duke University Children's Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Health Research and Innovation Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Completed
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Completed
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Completed
Facility Name
Temple University Lewis Katz School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Completed
Facility Name
LeBonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Completed
Facility Name
Child Neurology Consultants of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
ANRC Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Completed
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Completed
Facility Name
MultiCare Institute for Research and Innovation
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Completed
Facility Name
Children's Health Queensland Hospital
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
MHAT Sv. Ivan Rilski Gorna Oryahovitsa EOOD
City
Gorna Oryahovitsa
State/Province
Veliko Tarnovo
ZIP/Postal Code
5100
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment Puls AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Individual Site Status
Completed
Facility Name
UMHAT Kanev AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MHAT Lyulin EAD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Acibadem City Clinic MHAT Tokuda EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Diagnostic Consultative Center Neoclinic EAD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Diagnostic Consultative Center Equita EOOD
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Center Medica Plus OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Fakultní nemocnice v Motole
City
Praha 5
State/Province
Praha
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Completed
Facility Name
Fakultni nemocnice u sv. Anny v Brne, 1. Neurologicka klinika
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Completed
Facility Name
Nestatni zdravotnicke zarizeni, privatni ordinance neurologie
City
Hradec Králové
ZIP/Postal Code
500 03
Country
Czechia
Individual Site Status
Completed
Facility Name
Cerebrovaskularni poradna, s.r.o.
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Completed
Facility Name
Cerebovaskularni poradna s.r.o.
City
Ostrava-Vitkovice
ZIP/Postal Code
703 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Forbeli s.r.o., Neurologicka ordinace
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Vestra Clinics, s.r.o.
City
Rychnov Nad Kněžnou
ZIP/Postal Code
516 01
Country
Czechia
Individual Site Status
Completed
Facility Name
Neurologicka ambulance MUDr.Monika Zahumenska
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Completed
Facility Name
Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Individual Site Status
Recruiting
Facility Name
Sächsisches Epilepsiezentrum Kleinwachau gGmbH
City
Radeberg
ZIP/Postal Code
01454
Country
Germany
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Központ, Gyermekgyógyászati Intézet Nagyerdei krt. 98
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Csongrád Megyei Egészségügyi Elláto Központ Ideggyógyászati Osztály
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Individual Site Status
Completed
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
CHA Bundang Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
NZOZ Poradnia Zdrowia Psychicznego Antonijczuk Boleslaw
City
Tyniec Mały
State/Province
Dolnoslaskie
ZIP/Postal Code
55-040
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Oporów
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
City
Ksawerow
State/Province
Iodzkie
ZIP/Postal Code
95-054
Country
Poland
Individual Site Status
Completed
Facility Name
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Plejady
City
Krakow
State/Province
Malopolskie
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewódzki Specjalistyczny Szpital Dziecięcy im. sw. Ludwika sw Krakowie
City
Krakow
State/Province
Malopolskie
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Leczenia Padaczki i Migreny
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-209
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Warszawa Pratia s.a
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Individual Site Status
Completed
Facility Name
Gornoslaskie Centrum Medyczne - Samodzielny Publiczny Szpital Kliniczny Number 7
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Completed
Facility Name
M.A. LEK A.M. Maciejowscy S.C Centrum Terapii SM
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-571
Country
Poland
Individual Site Status
Completed
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Novo-Med
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-650
Country
Poland
Individual Site Status
Completed
Facility Name
Gyncentrum Clinic Sp. z.o.o
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-851
Country
Poland
Individual Site Status
Completed
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia Padaczki
City
Kielce
State/Province
Swietokrzyskie
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Centrum M Plejady
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
State/Province
Warminsko-Mazurskie
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Completed
Facility Name
Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R sp. k
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Individual Site Status
Completed
Facility Name
Konzílium, s.r.o
City
Dubnica Nad Váhom
State/Province
Trencin
ZIP/Postal Code
018 41
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
MUDr. Beata Dupejova, neurologická ambulncia, s.r.o
City
Banská Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Individual Site Status
Completed
Facility Name
IN MEDIC s.r.o
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Narodny Ustav Detskych Chorob
City
Bratislava
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
MEDBAJ, s.r.o., Neurologicka ambulancia, Nemocnicna 1944/10
City
Dolný Kubín
ZIP/Postal Code
026 01
Country
Slovakia
Individual Site Status
Completed
Facility Name
NEURES, s.r.o.-Neurologická Ambulancia
City
Krompachy
ZIP/Postal Code
053 42
Country
Slovakia
Individual Site Status
Completed
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Municipal Non-profit Enterprise City Clinical Hospital No.16 of Dnipro City Council, Department of Neurology
City
Dnipro
State/Province
Dnipropetrovsk
ZIP/Postal Code
49069
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Regional Center of Psychosomatic Disorders based on Psychoneurology Department
City
Dnepropetrovsk
State/Province
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv City Psychoneurological Hospital №2
City
Kiev
State/Province
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-Profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of Cerebro-Vascular Diseases with Neurosurgery
City
Odesa
State/Province
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-profit Enterprise Regional Clinical Center of Neurosurgery and Neurology of Zakarpattia Regional Council, Department of Neurosurgery #2
City
Uzhgorod
State/Province
Zakarpattia
ZIP/Postal Code
88018
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-Profit Enterprise Zaporizhzhia Regional Clinical Hospital Of Zaporizhzhia Regional Council
City
Zaporozhye
State/Province
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-profit Enterprise Prykarpattia Regional Clinical Center for Mental Health of Ivano-Frankivsk Regional Council
City
Ivano-Frankivsk
ZIP/Postal Code
76011
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional Clinical Psychiatric Hospital #3
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Non-Profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Neurological Department, Antiepileptic Center
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Non-Profit Enterprise Odesa Regional Medical Centre of Mental Health Odesa Regional Council, Department #2
City
Odessa
ZIP/Postal Code
67513
Country
Ukraine
Individual Site Status
Completed
Facility Name
Odessa Regional Psychiatric Hospital No. 2,
City
Odessa
ZIP/Postal Code
67513
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Enterprise Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev of Poltava Regional Council
City
Poltava
ZIP/Postal Code
36000
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-Profit Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Neurology #2
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-profit Enterprise Vinnytsia Regional Clinical Psychoneurological Hospital named after Acad. O.I. Yushchenko of Vinnytsia Regional Council, Department of Neurology #3
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35605481
Citation
Rosenfeld WE, Ferrari L, Kamin M. Efficacy of cenobamate by focal seizure subtypes: Post-hoc analysis of a phase 3, multicenter, open-label study. Epilepsy Res. 2022 Jul;183:106940. doi: 10.1016/j.eplepsyres.2022.106940. Epub 2022 May 5.
Results Reference
derived

Learn more about this trial

Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

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