Partial EpilepsyPhase 2NCT01866111

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

A Phase 2 study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc. at 67 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Partial Epilepsy
What is being tested?: YKP3089
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 437 participants
Where: 67 sitesin 15 countries
Study dates: 31 Jul 2013to 31 Oct 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Weight at least 40 kg
A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
Currently on stable antiepileptic treatment regimen.

Who cannot join

A history of nonepileptic or psychogenic seizures
Presence of only nonmotor simple partial seizures or primary generalized epilepsies
Presence or previous history of Lennox-Gastaut syndrome
An active 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
Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
History of alcoholism, drug abuse, or drug addiction within the past 2 years

Show all 11Show fewer

History of status epilepticus within 3 months of Visit 1
A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
More than 1 lifetime suicide attempt
Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
A history of any previous exposure to YKP3089

Trial locations and contacts

67 sites in 15 countries.

Country

City, postcode or hospital

67 sites in 15 countries

United States21 sites

Kaiser Permanente, Department of Neurology
Anaheim, California, 92806
Austin Epilepsy Care Center
Austin, Texas, 78758
Johns Hopkins University
Baltimore, Maryland, 21287
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
The Neurological Institute, PA
Charlotte, North Carolina, 28204
University of Virginia Comprehensive Epilepsy Program
Charlottesville, Virginia, 22903
Neuro-Pain Medical Center
Fresno, California, 93710
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
West Los Angeles VA Medical Center, Clinical Research Center
Los Angeles, California, 90073
Vanderbilt Epilepsy Clinic
Nashville, Tennessee, 37232
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Thomas Jefferson Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, 85013
Lovelace Scientific Resources, Inc.
Sarasota, Florida, 34233
The Comprehensive Epilepsy Care Center for Children and Adults
St Louis, Missouri, 63017
Neuroresearch, Inc. - Torrance
Torrance, California, 90505
Neuroresearch II, Inc.
Ventura, California, 93003
Neurology Clinic PC
Waldorf, Maryland, 20603

Other trials in United States

Australia5 sites

Monash Medical Centre
Clayton, Victoria, 3168
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065
Epilepsy Research Centre, Melbourne Brain Centre
Heidelberg, Victoria, 3084
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Institute of Neurological Sciences, Prince of Wales Hospital
Randwick, New South Wales, 2031

Other trials in Australia

Poland5 sites

M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, 40-595
NOVO-MED Zielinski I Wspolnicy Spolka Jawna
Katowice, 40-650
NZOZ Centrum Medyczne "Dendryt"
Katowice, 40-662
Fundacja Epileptologii profesora Jerzego Majkowskiego
Warsaw, 02-952
Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna
Warsaw, 02-957

Other trials in Poland

South Korea5 sites

Dong-A University Hospital
Busan, 602715
Seoul National University Hospital
Seoul, 110744
Samsung Medical Center
Seoul, 135710
Asan Medical Center
Seoul, 138736
Konkuk University Medical Center
Seoul, 143729

Other trials in South Korea

Spain5 sites

Hospital Universitario San Cecilio - Servicio de Neurologia
Granada, 18012
Hospital Ruber Internacional - Programa Epilepsia
Madrid, 28034
Fundación Jiminez Diaz-Servicio de Neurologia
Madrid, 28040
Hospital Clinico Universitario San Carlos, Serv. Neurologia
Madrid, 28040
Hospital Universitario y Politecnico La Fe - Servicio Neurologia
Valencia, 46026

Other trials in Spain

Ukraine5 sites

Neurology of Kharkiv Medical Academy of Postgraduate Education based on Department of Neurology #3 of State Treatment and Prevention Institution "Central Clinical Hospital of Ukrzaliznytsya"
Kharkiv, 61103
TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"
Kyiv, 04080
Lviv Regional Antiepileptic Center based on Department of Neurology of Lviv Regional Clinical Hospital and Chair of Neurology of Lviv National Medical University n.a. Danylo Galytskyy
Lviv, 79010
MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department
Odesa, 65025
Department #2 of Regional Clinical Center of Neurosurgery and Neurology
Uzhhorod, 88018

Other trials in Ukraine

Bulgaria3 sites

University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases
Plovdiv, 4002
"First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic
Sofia, 1142
University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases
Sofia, 1606

Other trials in Bulgaria

Czechia3 sites

Fakultní nemocnice Ostrava, Neurologická klinika
Ostrava, 70825
Mediscan Group, s.r.o
Prague, 148 00
Fakultni nemocnice v Motole, Neurologická klinika
Prague, 150 06

Other trials in Czechia

Germany3 sites

Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"
Bernau bei Berlin, 16321
Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel
Bielefeld, 33617
Epilepsiezentrum Kork
Kehl, 77694

Other trials in Germany

Israel3 sites

Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah
Jerusalem, 91120
Western Galilee Hospital, Department of Neurology
Nahariya, 22100
The Chaim Sheba Medical Center, Department of Neurology
Ramat Gan, 52621

Other trials in Israel

Serbia3 sites

Clinical of Neurology, Clinical Center of Serbia
Belgrade, 11000
Institute of Mental Health
Belgrade, 11000
Clinical Hospital Center Kragujevac
Kragujevac, 34000

Other trials in Serbia

France2 sites

CHU - Service Neurophysiologie Clinique
Dijon, 21079
Hôpital Central - CHU de Nancy - Service de Neurologie
Nancy, 5400

Other trials in France

Romania2 sites

Roceanu Adina Maria Neurology Individual Medical Center
Bucharest, 010042
Sapiens Medical Center SRL
Bucharest, 011635

Other trials in Romania

Hungary1 site

Országos Klinikai Idegtudományi Intézet
Budapest, 1145

Other trials in Hungary

Thailand1 site

Srinagarind Hospital
Na Muang, Changwat Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

Conditions: Partial Epilepsy
Being tested: YKP3089, Placebo
Medical subject headings: Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YKP3089Drug
PlaceboDrug

Study groups in NCT01866111
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
YKP3089 Low Dose	Experimental	YKP3089 Low Dose Receives: Drug: YKP3089
YKP3089 Medium Dose	Experimental	YKP3089 Medium Dose Receives: Drug: YKP3089
YKP3089 High Dose	Experimental	YKP3089 High Dose Receives: Drug: YKP3089

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
Measured: baseline and 18 weeks

Secondary outcomes (1)

50% Responder Rate
Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 201331 Oct 2021

First posted31 May 2013 (estimated)
Study start31 Jul 2013
Primary completion5 Apr 2021
Study completion31 Oct 2021

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 (4)Papers the sponsor has linked to this study.
Other trials for Partial 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 437 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01866111
Sponsor's protocol ID: YKP3089C017
Status last verified: Jun 2025
First submitted: 28 May 2013
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Klein P, Aboumatar S, Brandt C, Dong F, Krauss GL, Mizne S, Sanchez-Alvarez JC, Steinhoff BJ, Villanueva V. Long-term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. Neurology. 2022 Sep 5;99(10):e989-e998. doi: 10.1212/WNL.0000000000200792.
PubMed 35705501
Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.
PubMed 33662894
Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14.
PubMed 31734103
Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19.
PubMed 25769377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Peri-procedural Weighted Blanket Use for ECT
Post-ect Agitation, Post-ictal Agitation
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy

All Partial Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension
ClinicalTrials.gov ID: NCT01866111
Acronym / sponsor ID: YKP3089C017
Conditions: Partial Epilepsy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 437 participants (actual)
Lead sponsor: SK Life Science, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jul 2013 (actual)
Primary completion: 5 Apr 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 31 May 2013 (estimated)
Results: Posted 29 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
YKP3089 Low Dose	Experimental	Drug: YKP3089YKP3089 Low Dose
YKP3089 Medium Dose	Experimental	Drug: YKP3089YKP3089 Medium Dose
YKP3089 High Dose	Experimental	Drug: YKP3089YKP3089 High Dose

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Weight at least 40 kg
A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
Currently on stable antiepileptic treatment regimen.

Key exclusion criteria (11 listed)

A history of nonepileptic or psychogenic seizures
Presence of only nonmotor simple partial seizures or primary generalized epilepsies
Presence or previous history of Lennox-Gastaut syndrome
An active 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
Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in 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
YKP3089	Drug	YKP3089 High Dose, YKP3089 Low Dose, YKP3089 Medium Dose
Placebo	Drug	Placebo

Primary outcome

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Time frame: baseline and 18 weeks
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.

1 secondary outcome

50% Responder Rate
Time frame: 18 weeks

Results and safety

Results posted to the registry on 29 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	108	94
Cenobamate 100 mg/Day	108	95
Cenobamate 200 mg/Day	110	90
Cenobamate 400 mg/Day	111	81

Primary outcome: Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days

Time frame: baseline and 18 weeks. Median (Full Range). Unit: percent change

Measure	Placebo n = 106	Cenobamate 100 mg/Day n = 108	Cenobamate 200 mg/Day n = 109	Cenobamate 400 mg/Day n = 111
Value	-24.0 (-91 to 198)	-35.5 (-100 to 206)	-55.0 (-100 to 191)	-55.0 (-100 to 167)

Placebo vs Cenobamate 200 mg/Day: p <0.001, ANCOVA
Placebo vs Cenobamate 400 mg/Day: p <0.001, ANCOVA
Placebo vs Cenobamate 100 mg/Day: p = 0.007, ANCOVA

Population analysed: All randomly assigned patients who took at least one dose of study drug and had any post-baseline seizure data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6.75 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 108 (5.6%)	76 of 108 (70.4%)	0 of 108
Cenobamate 100 mg/Day	10 of 108 (9.3%)	70 of 108 (64.8%)	0 of 108
Cenobamate 200 mg/Day	4 of 110 (3.6%)	84 of 110 (76.4%)	0 of 110
Cenobamate 400 mg/Day	8 of 111 (7.2%)	100 of 111 (90.1%)	0 of 111
100mg/Day Open-Label Extension	21 of 95 (22.1%)	87 of 95 (91.6%)	1 of 95
200mg/Day Open-Label Extension	17 of 90 (18.9%)	80 of 90 (88.9%)	3 of 90
400mg/Day Open-Label Extension	21 of 80 (26.3%)	70 of 70 (100%)	3 of 80
Placebo Open-Label Extension	20 of 91 (22%)	80 of 80 (100%)	2 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35705501Klein P, Aboumatar S, Brandt C, Dong F, Krauss GL, Mizne S, Sanchez-Alvarez JC, Steinhoff BJ, Villanueva V. Long-term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. Neurology. 2022 Sep 5;99(10):e989-e998. doi: 10.1212/WNL.0000000000200792.
Derived from this study: PubMed 33662894Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.
Derived from this study: PubMed 31734103Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14.
Derived from this study: PubMed 25769377Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19.

Related trials for Partial Epilepsy

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Peri-procedural Weighted Blanket Use for ECT
Post-ect Agitation, Post-ictal Agitation
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy

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.

The record lists no contact. Use the official record to reach the sponsor.

67 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc. at 67 sites in 15 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 5 inclusion and 11 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Australia, Poland, South Korea, Spain and 10 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days (time frame: baseline and 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01866111, which also lists 4 linked publications.

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 24 Jun 2025.