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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YKP3089 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YKP3089 | Drug | Capsule, dose to be titrated Tablet, dose to be titrated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | assessed per 28 days during 12 week period; change from baseline and 12 weeks reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
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 :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Kamin, MD | SK Life Science, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital & Medical Center/Barrow Neurology Clinic | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34254673 | Derived | 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. | |
| 32409485 | Derived |
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There were 285 patients screened; 63 were excluded before assignment to study group for reasons as follows:
inclusion/exclusion criteria, withdrew by patient, other, lost to follow-up.
Enrollment occurred in 4 countries (United States, Poland, Korea, India) between 06 July 2011 and 15 June 2013 when the last subject completed the double-blind period.
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| ID | Title | Description |
|---|---|---|
| FG000 | YKP3089 | YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day |
| FG001 | Placebo | Placebo: capsule, dose to be titrated to a target dose of 200mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period of Study YKP3089C013 |
|
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| Placebo | Drug | Placebo capsule Placebo tablet |
|
| Clinical Trials, Inc. |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Kaiser Permanente | Anaheim | California | 92806 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | United States |
| Bluegrass Epilepsy Research, LLC | Lexington | Kentucky | 40504 | United States |
| John's Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Suite 209 South | Chesterfield | Missouri | 63017 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| The University of Toledo | Toledo | Ohio | 43614 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Comprehensive Epilepsy Center | Philadelphia | Pennsylvania | 19107 | United States |
| Neurological Clinic of Texas, P.A. | Dallas | Texas | 75230 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| St. Theresa's General Hospital | Hyderabad | Andhra Pradesh | 500 018 | India |
| M.S. Ramaiah Medical College and Hospital | Bangalore | Karnataka | 560 054 | India |
| Bangalore Clinisearch | Bangalore | Karnataka | 560043 | India |
| Mallikatta Neuro Centre | Mangalore | Karnataka | 575 002 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411004 | India |
| Max Super Specialty Hospital | Sāket | New Delhi | 110 017 | India |
| Nightingale Hospital | Kolkata | West Bengal | 700 071 | India |
| NZOZ Vito-Med Sp. Zo.o | Gliwice | 44-100 | Poland |
| NZOZ Diagnomed | Katowice | 40-594 | Poland |
| SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca | Katowice | 40-635 | Poland |
| Malopolskie Centrum Medyczne | Krakow | 30-510 | Poland |
| Centrum Leczenia Padaczki i Migreny | Krakow | 31-209 | Poland |
| Centrum Terapii Wspolczesnej | Lodz | 90-242 | Poland |
| Solumed s.c. | Poznan | 60-539 | Poland |
| Dong-A University Medical Center | Busan | 602-715 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 700-712 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | 431-070 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Chung 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. |
| 23219031 | Derived | Bialer 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Open-label Extension Study YKP3089C013 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | YKP3089 | YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day |
| BG001 | Placebo | Placebo: capsule, dose to be titrated to a target dose of 200mg/day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 28-day partial-onset seizure frequency | Median | Full Range | seizures/28 days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Full Range | percent seizure reduction | assessed per 28 days during 12 week period; change from baseline and 12 weeks reported |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 week double-blind treatment period plus taper period (2-3 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YKP3089 | YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day | 0 | 113 | 3 | 113 | 86 | 113 |
| EG001 | Placebo | Placebo: capsule, dose to be titrated to a target dose of 200mg/day | 0 | 109 | 4 | 109 | 69 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug hypersensitivity reaction | Immune system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Arteriogram coronary normal | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | SK Life Science | 201-421-3830 | mkamin@sklsi.com |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Poland |
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| India |
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