Clinical trial NCT01397968: Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Partial Epilepsy
Keywords: partial onset seizures
treatment resistant
partial epilepsy
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 :

  * 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.

Exclusion Criteria:

1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
2. Subject has had status epilepticus within past 1 year.
3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
4. Subjects taking felbamate with less than 18 months continuous exposure.
5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
8. Subject meets criteria for current major depressive episode (within 6 months).
9. 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.

Primary outcomes:
measure: Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
timeFrame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Secondary outcomes:
measure: 50% Responder Rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Lexington
country: United States
facility: Bluegrass Epilepsy Research, LLC
state: Kentucky
city: Baltimore
country: United States
facility: John's Hopkins University School of Medicine
state: Maryland
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Chesterfield
country: United States
facility: Suite 209 South
state: Missouri
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Comprehensive Epilepsy Center
state: Pennsylvania
city: Dallas
country: United States
facility: Neurological Clinic of Texas, P.A.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Hyderabad
country: India
facility: St. Theresa's General Hospital
state: Andhra Pradesh
city: Bangalore
country: India
facility: M.S. Ramaiah Medical College and Hospital
state: Karnataka
city: Bangalore
country: India
facility: Bangalore Clinisearch
state: Karnataka
city: Mangalore
country: India
facility: Mallikatta Neuro Centre
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Saket
country: India
facility: Max Super Specialty Hospital
state: New Delhi
city: Kolkata
country: India
facility: Nightingale Hospital
state: West Bengal
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gliwice
country: Poland
facility: NZOZ Vito-Med Sp. Zo.o
city: Katowice
country: Poland
facility: NZOZ Diagnomed
city: Katowice
country: Poland
facility: SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Krakow
country: Poland
facility: Centrum Leczenia Padaczki i Migreny
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej
city: Poznan
country: Poland
facility: Solumed s.c.
Study officials:
affiliation: SK Life Science, Inc.
name: Marc Kamin, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.