Partial EpilepsyPhase 2NCT01397968
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
A Phase 2 study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc. at 38 sites in 4 countries.
Trial summary
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- YKP3089
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 38 sitesin 4 countries
- Study dates
- 6 Jul 2011to 28 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of treatment resistant partial epilepsy;
- History of epilepsy for at least 2 years;
- Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
- Currently treated on a stable dose of :
- 1 - 3 AED's for at least 12 weeks prior to randomization.
- VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
- Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.
Who cannot join
- A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- Subject has had status epilepticus within past 1 year.
- Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- Subjects taking felbamate with less than 18 months continuous exposure.
- Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
- No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
Show all 9Show fewer
- History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
- Subject meets criteria for current major depressive episode (within 6 months).
- Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
Trial locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
United States16 sites
Kaiser Permanente
Anaheim, California, 92806
John's Hopkins University School of Medicine
Baltimore, Maryland, 21287
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
University of Virginia
Charlottesville, Virginia, 22903
Suite 209 South
Chesterfield, Missouri, 63017
Ohio State University Medical Center
Columbus, Ohio, 43210
Neurological Clinic of Texas, P.A.
Dallas, Texas, 75230
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, 40504
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107
St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
Phoenix, Arizona, 85013
The University of Toledo
Toledo, Ohio, 43614
South Korea8 sites
Dong-A University Medical Center
Busan, 602-715
Keimyung University Dongsan Hospital
Daegu, 700-712
Chungnam National University Hospital
Daejeon, 301-721
Hallym University Sacred Heart Hospital
Gyeonggi-do, 431-070
Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center
Seoul, 138-736
India7 sites
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560 054
Bangalore Clinisearch
Bangalore, Karnataka, 560043
St. Theresa's General Hospital
Hyderabad, Andhra Pradesh, 500 018
Nightingale Hospital
Kolkata, West Bengal, 700 071
Mallikatta Neuro Centre
Mangalore, Karnataka, 575 002
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
Max Super Specialty Hospital
Sāket, New Delhi, 110 017
Poland7 sites
NZOZ Vito-Med Sp. Zo.o
Gliwice, 44-100
NZOZ Diagnomed
Katowice, 40-594
SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
Katowice, 40-635
Malopolskie Centrum Medyczne
Krakow, 30-510
Centrum Leczenia Padaczki i Migreny
Krakow, 31-209
Centrum Terapii Wspolczesnej
Lodz, 90-242
Solumed s.c.
Poznan, 60-539
About this study
Official title: A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.
Also to evaluate the safety and tolerability of YKP3089.
- Conditions
- Partial Epilepsy
- Being tested
- YKP3089, Placebo
- Keywords
- partial onset seizures, treatment resistant, partial epilepsy
- 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
Also called cenobamate
Capsule, dose to be titrated Tablet, dose to be titrated
PlaceboDrug
Placebo capsule Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| YKP3089 | Experimental | Not described Receives: Drug: YKP3089 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline
Measured: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Secondary outcomes (1)
50% Responder Rate
Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study start6 Jul 2011
- Primary completionJun 2013
- Study completion28 Jan 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 (3)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Kamin, MD, Study director, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397968
- Sponsor's protocol ID
- YKP3089C013
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2011
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.
PubMed 34254673Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.
PubMed 32409485Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.
PubMed 23219031
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT01397968
- Acronym / sponsor ID
- YKP3089C013
- Conditions
- Partial Epilepsy
- Keywords
- partial onset seizures, treatment resistant, partial epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 11 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.
Also to evaluate the safety and tolerability of YKP3089.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YKP3089 | Experimental | Drug: YKP3089 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of treatment resistant partial epilepsy;
- History of epilepsy for at least 2 years;
- Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
- Currently treated on a stable dose of :
Key exclusion criteria (9 listed)
- A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- Subject has had status epilepticus within past 1 year.
- Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- Subjects taking felbamate with less than 18 months continuous exposure.
- Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
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 |
|---|---|---|
| YKP3089Also: cenobamateCapsule, dose to be titrated Tablet, dose to be titrated | Drug | YKP3089 |
| PlaceboPlacebo capsule Placebo tablet | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Time frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline
1 secondary outcome
50% Responder Rate
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34254673French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.
- Derived from this study: PubMed 32409485Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.
- Derived from this study: PubMed 23219031Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.
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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.
Marc Kamin, MD study director
SK Life Science, Inc.
38 sites in 4 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 38 sites in 4 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 7 inclusion and 9 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, South Korea, India, Poland. 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 11 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: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported). 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 NCT01397968, which also lists 3 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 11 Apr 2022.