Primary Generalized EpilepsyPhase 3NCT03678753
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
A Phase 3 study testing Cenobamate in people with Primary Generalized Epilepsy, run by SK Life Science, Inc. at 116 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Primary Generalized Epilepsy
- What is being tested?
- Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 116 sitesin 12 countries
- Study dates
- 3 Oct 2018to 26 May 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
116 sites in 12 countries.
116 sites in 12 countries
United States43 sites
PMG Research of McFarland Clinic
Ames, Iowa, 50010
Clinical Integrative Research Center of Atlanta, CIRCA
Atlanta, Georgia, 30328
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Child Neurology Consultants of Austin
Austin, Texas, 78757
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Consultants in Epilepsy and Neurology
Boise, Idaho, 83702
New York Presbyterian Hospital
Brooklyn, New York, 11215
UBMD Neurology
Buffalo, New York, 14203
Rush University
Chicago, Illinois, 60612
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
University of Missouri Health Care
Columbia, Missouri, 65201
Ohio Health Research and Innovation Institute
Columbus, Ohio, 43214
Duke University Children's Health Center
Durham, North Carolina, 27710
Michigan State University
East Lansing, Michigan, 48824
JFK Medical Center- The Neuroscience Institute
Edison, New Jersey, 08818
ANRC Research
El Paso, Texas, 79912
Neuro Pain Medical Center
Fresno, California, 93710
Minneapolis Clinic of Neurology Golden Valley
Golden Valley, Minnesota, 55422
Children's Hospital of Colorado
Grand Junction, Colorado, 80045
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96814
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Kentucky
Lexington, Kentucky, 40536
LeBonheur Children's Medical Center
Memphis, Tennessee, 38105
Brainstorm Research
Miami, Florida, 33176
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Florida Hospital Medical Group
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Temple University Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Valley Medical Center
Renton, Washington, 98057
Carilion Clinic
Roanoke, Virginia, 24016
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Utah / Primary Children's Hospital
Salt Lake City, Utah, 84113
Maine Medical Center
Scarborough, Maine, 04074
MultiCare Institute for Research and Innovation
Spokane, Washington, 99204
University of South Florida
Tampa, Florida, 33606
University of Toledo
Toledo, Ohio, 43606
Center for Neurosciences
Tuscon, Arizona, 85718
Five Towns Neuroscience Research
Woodmere, New York, 11598
Ukraine17 sites
Municipal Non-profit Enterprise City Clinical Hospital No.16 of Dnipro City Council, Department of Neurology
Dnipro, Dnipropetrovsk Oblast, 49069
Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Regional Center of Psychosomatic Disorders based on Psychoneurology Department
Dnipro, Dnipro, 49005
Communal Enterprise Regional Medical Center of Family Health of the Dnipropetrovsk Regional Council
Dnipro, 49000
Communal Non-commercial Enterprise City Children's Clinical Hospital 6 of Dnipro City Council
Dnipro, 49009
Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council
Dnipropetrovsk, Dnipropetrovsk Oblast, 49005
Municipal Non-profit Enterprise Prykarpattia Regional Clinical Center for Mental Health of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76011
Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional Clinical Psychiatric Hospital #3
Kharkiv, Kharkiv Oblast, 61068
Kyiv City Psychoneurological Hospital №2
Kiev, Kyiv Oblast, 02192
Communal Non-Profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Neurological Department, Antiepileptic Center
Lviv, Lviv Oblast, 79010
Municipal Non-Profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of Cerebro-Vascular Diseases with Neurosurgery
Odesa, Odesa Oblast, 65025
Communal Non-Profit Enterprise Odesa Regional Medical Centre of Mental Health Odesa Regional Council, Department #2
Odesa, Odesa Oblast, 67513
Odessa Regional Psychiatric Hospital No. 2,
Odesa, 67513
Communal Enterprise Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev of Poltava Regional Council
Poltava, 36000
Municipal Non-Profit Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Neurology #2
Ternopil, 46020
Municipal Non-profit Enterprise Regional Clinical Center of Neurosurgery and Neurology of Zakarpattia Regional Council, Department of Neurosurgery #2
Uzhhorod, Zakarpattia Oblast, 88018
Municipal Non-profit Enterprise Vinnytsia Regional Clinical Psychoneurological Hospital named after Acad. O.I. Yushchenko of Vinnytsia Regional Council, Department of Neurology #3
Vinnytsia, Vinnytsya, 21005
Municipal Non-Profit Enterprise Zaporizhzhia Regional Clinical Hospital Of Zaporizhzhia Regional Council
Zaporizhzhya, Zaporizhzhya, 69600
Poland16 sites
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081
M.A. LEK A.M. Maciejowscy S.C Centrum Terapii SM
Katowice, Silesian Voivodeship, 40-571
Gornoslaskie Centrum Medyczne - Samodzielny Publiczny Szpital Kliniczny Number 7
Katowice, Silesian Voivodeship, 40-635
Niepubliczny Zaklad Opieki Zdrowotnej Novo-Med
Katowice, Silesian Voivodeship, 40-650
Gyncentrum Clinic Sp. z.o.o
Katowice, Silesian Voivodeship, 40-851
Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia Padaczki
Kielce, Świętokrzyskie Voivodeship
Centrum Leczenia Padaczki i Migreny
Krakow, Lesser Poland Voivodeship, 31-209
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship
Wojewódzki Specjalistyczny Szpital Dziecięcy im. sw. Ludwika sw Krakowie
Krakow, Lesser Poland Voivodeship
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
Ksawerów, Iodzkie, 95-054
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
Lublin, Lublin Voivodeship, 20-090
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-561
Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R sp. k
Poznan, Greater Poland Voivodeship, 60-848
NZOZ Poradnia Zdrowia Psychicznego Antonijczuk Boleslaw
Tyniec Mały, Lower Silesian Voivodeship, 55-040
Centrum Medyczne Warszawa Pratia s.a
Warsaw, Masovian Voivodeship, 01-868
Centrum Medyczne Oporów
Wroclaw, Lower Silesian Voivodeship, 52-416
Bulgaria8 sites
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, Blagoevgrad, 2700
MHAT Sv. Ivan Rilski Gorna Oryahovitsa EOOD
Gorna Oryahovitsa, Veliko Tarnovo, 5100
UMHAT Kanev AD
Rousse, Ruse, 7002
MHAT Lyulin EAD
Sofia, Sofia, 1336
Acibadem City Clinic MHAT Tokuda EAD
Sofia, Sofia, 1407
Diagnostic Consultative Center Neoclinic EAD
Sofia, Sofia, 1408
Diagnostic Consultative Center Equita EOOD
Varna, Varna, 9000
Medical Center Medica Plus OOD
Veliko Tarnovo, Veliko Tarnovo, 5000
Czechia8 sites
Fakultni nemocnice u sv. Anny v Brne, 1. Neurologicka klinika
Brno, 656 91
Nestatni zdravotnicke zarizeni, privatni ordinance neurologie
Hradec Králové, 500 03
Cerebrovaskularni poradna, s.r.o.
Ostrava-Poruba, 708 52
Cerebovaskularni poradna s.r.o.
Ostrava-Vitkovice, 703 00
Fakultní nemocnice v Motole
Prague, Prague, 150 06
Forbeli s.r.o., Neurologicka ordinace
Prague, 160 00
Vestra Clinics, s.r.o.
Rychnov nad Kněžnou, 516 01
Neurologicka ambulance MUDr.Monika Zahumenska
Zlín, 760 01
Slovakia6 sites
MUDr. Beata Dupejova, neurologická ambulncia, s.r.o
Banská Bystrica, 974 04
IN MEDIC s.r.o
Bardejov, 085 01
Narodny Ustav Detskych Chorob
Bratislava
MEDBAJ, s.r.o., Neurologicka ambulancia, Nemocnicna 1944/10
Dolný Kubín, 026 01
Konzílium, s.r.o
Dubnica nad Váhom, Trenčín Region, 018 41
NEURES, s.r.o.-Neurologická Ambulancia
Krompachy, 053 42
Germany4 sites
Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum
Berlin, 13353
Universitätsklinikum Jena
Jena
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105
Sächsisches Epilepsiezentrum Kleinwachau gGmbH
Radeberg, 01454
South Korea4 sites
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
SMG-SNU Boramae Medical Center
Seoul, Gyeonggi-do
Ajou University Hospital
Suwon
Hungary3 sites
Semmelweis Egyetem
Budapest, Budapest, 1083
Debreceni Egyetem Klinikai Központ, Gyermekgyógyászati Intézet Nagyerdei krt. 98
Debrecen
Csongrád Megyei Egészségügyi Elláto Központ Ideggyógyászati Osztály
Hódmezővásárhely, 6800
Spain3 sites
Hospital Clínico San Carlos
Madrid, 28040
Hospital Regional Universitario de Malaga
Málaga, 29011
Hospital Universitario La Fe
Valencia, 46026
Australia2 sites
Austin Health
Heidelberg, 3084
Children's Health Queensland Hospital
South Brisbane, 4101
Georgia2 sites
LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry
Tbilisi, 0159
Institute of Neurology and Neuropsychology LTD
Tbilisi, 0186
About this study
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
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. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension 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.
Read the 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. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension 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.
- Conditions
- Primary Generalized Epilepsy
- Being tested
- Cenobamate, Placebo
- Keywords
- Primary Generalized Tonic-Clonic Seizures, PGTC, Idiopathic Generalized Epilepsy, Generalized Tonic-Clonic Seizures
- Medical subject headings
- Epilepsy, Idiopathic Generalized, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
Also called YKP3089
12.5 mg tablet, 25 mg tablet, 50 mg tablet, 100 mg tablets, 150 mg tablets, 200 mg tablets. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.
PlaceboDrug
Also called PBO
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cenobamate | Experimental | 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. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Receives: Drug: Cenobamate |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
USA and Rest of World (RoW): Percent Change in PGTC Seizure Frequency Per 28 Days During the Double-blind Treatment Period Relative to Baseline.
The seizure frequency over a specified period was calculated based on available seizure diary data. The percent change from baseline in PGTC seizure frequency during the Double-blind Treatment Period was calculated as the seizure frequency per 28-day interval during the Double-blind Treatment Period minus the seizure frequency per 28-day interval during the baseline period divided by the seizure frequency per 28-day interval during the baseline period and multiplied by 100%.
Measured: Baseline and 22-week Double-blind Treatment Period.
Europe, South Africa, Australia, and New Zealand: 50% Responder Rate for PGTC Seizures During the Maintenance Phase Relative to Baseline.
A responder was defined as a participant who achieved at least a 50% reduction in PGTC seizure frequency per 28-day interval during the Maintenance Phase relative to baseline. The percent change from baseline in PGTC seizure frequency during the Maintenance Phase was calculated as the seizure frequency per 28-day interval during the Maintenance Phase minus the seizure frequency per 28-day interval during the baseline period divided by the seizure frequency per 28-day interval during the baseline period and multiplied by 100%.
Measured: Baseline and 12-week Maintenance Phase.
Secondary outcomes (3)
100% Responder Rate for PGTC Seizures During the Maintenance Phase Relative to Baseline.
A responder was defined as a participant who achieved a 100% reduction in PGTC seizure frequency per 28-day interval during the Maintenance Phase relative to baseline.
Measured: Baseline and 12-week Maintenance Phase.
75% Responder Rate for PGTC Seizures During the Maintenance Phase Relative to Baseline.
A responder was defined as a participant who achieved at least a 75% reduction in PGTC seizure frequency per 28-day interval during the Maintenance Phase relative to baseline.
Measured: Baseline and 12- week Maintenance Phase
50% Responder Rate for All Generalized Seizures During the Maintenance Phase Relative to Baseline.
A responder was defined as a participant who achieved at least a 50% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to baseline.
Measured: Baseline and 12-week Maintenance Phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start3 Oct 2018
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Generalized EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunita Misra, MD, Study director, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678753
- Sponsor's protocol ID
- YKP3089C025
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2018
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brigo F, Lattanzi S. Cenobamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2024 Aug 1;8(8):CD014941. doi: 10.1002/14651858.CD014941.pub2.
PubMed 39087564Rosenfeld 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.
PubMed 35605481