Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized EpilepsyPhase 3NCT03961568
Cenobamate Open-Label Extension Study for YKP3089C025
A Phase 3 study testing Cenobamate in people with Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy, run by SK Life Science, Inc. at 45 sites in 7 countries.
Trial summary
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
- What is being tested?
- Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 45 sitesin 7 countries
- Study dates
- 13 Aug 2019to 10 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- The subject must have successfully completed the Double-blind Treatment Period in the Core study.
- Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. 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 ICF in accordance with ICH guidelines.
Who cannot join
- Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
- Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
United States16 sites
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702
University of Missouri Medical School
Columbia, Missouri, 01074
Duke University
Durham, North Carolina, 27705
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96814
University of California, San Diego (UCSD)
La Jolla, California, 92093
The Neurology Research Group, LLC.
Miami, Florida, 33176
University of Pennsylvania
Philadelphia, Pennsylvania, 19140
Valley Medical Center
Renton, Washington, 98057
Mayo Clinic - Rochester
Rochester, Minnesota, 01056
Maine Medical Center
Scarborough, Maine, 04074
MultiCare Rockwood Neurology Center
Spokane, Washington, 99204
University of South Florida
Tampa, Florida, 33606
Five Towns Neuroscience Research
Woodmere, New York, 11598
Ukraine11 sites
Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council
Dnipro, Dnipropetrovsk Oblast, 49027
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center
Dnipro, 49005
Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"
Dnipro, 49005
Regional Psyconeurology Hospital #3
Ivano-Frankivsk, 76011
Communal Non-Commercial Enterprise of Kharkiv Regional Council
Kharkiv, 61068
Municipal Institution of Lviv Regional Council
Lviv, 79010
Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases
Odesa, Odesa Oblast, 65025
Ternopil Regional Municipal Psychoneurological Hospital
Ternopil, 46020
Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"
Uzhhorod, Zakarpattia Oblast, 88018
Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch
Vinnytsia, 21005
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhya, Zaporizhzhya, 69600
Bulgaria6 sites
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, Blagoevgrad, 2700
Acibadem City Clinic Multiprofile Hospital for Active Treatment 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
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD
Veliko Tarnovo, Veliko Tarnovo, 5100
Czechia4 sites
Cerebrovaskularni poradna
Ostrava-Poruba, 708 52
Fakultni nemocnice v Motole
Prague, 150 06
Forbeli s.r.o.-Neurologicka ambulance
Prague, 160 00
Neurologicka ambulance
Zlín, 760 01
Poland4 sites
Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, 40-635
Centrum Leczenia Padaczki i Migreny
Krakow, Lesser Poland Voivodeship, 31-209
Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.
Poznan, Greater Poland Voivodeship, 60-848
Centrum Medyczne Pratia Warszawa
Warsaw, Masovian Voivodeship, 01-868
Slovakia3 sites
MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.
Banská Bystrica, 974 04
IN MEDIC s.r.o.
Bardejov, 085 01
Konzilium, s.r.o.
Dubnica nad Váhom, 018 41
Hungary1 site
Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika
Budapest, 1083
About this study
Official title: A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
Read the detailed description
52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures.
Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight
- Conditions
- Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
- Being tested
- Cenobamate
- Keywords
- Idiopathic Generalized Epilepsy
- Medical subject headings
- Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
Also called YKP3089
active drug
| Study group | Role | What they receive |
|---|---|---|
| Core Study Placebo | Experimental | Subjects who did not receive Cenobamate in the Core Study will receive 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 |
| Core Study Active | Experimental | Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg).
Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and SAEs
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.
Measured: 386 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start13 Aug 2019
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 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
- NCT03961568
- Sponsor's protocol ID
- YKP3089C033
- Status last verified
- Jun 2026
- First submitted
- 21 May 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures
- ClinicalTrials.gov ID
- NCT03961568
- Acronym / sponsor ID
- YKP3089C033
- Conditions
- Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
- Keywords
- Idiopathic Generalized Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
Detailed description
52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures.
Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Study Placebo | Experimental | Drug: CenobamateSubjects who did not receive Cenobamate in the Core Study will receive 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. |
| Core Study Active | Experimental | Drug: CenobamateSubjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The subject must have successfully completed the Double-blind Treatment Period in the Core study.
- Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. 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 ICF in accordance with ICH guidelines.
Key exclusion criteria (2 listed)
- Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
- Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenobamateAlso: YKP3089active drug | Drug | Core Study Active, Core Study Placebo |
Primary outcome
Incidence of Adverse Events and SAEs
Time frame: 386 +/- 2 days
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Misra, MD study director
SK Life Science, Inc.
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cenobamate in people with Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy, run by SK Life Science, Inc. at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Ukraine, Bulgaria, Czechia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and SAEs (time frame: 386 +/- 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.