Brief 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 study) or a 2-week blinded conversion period (for subjects who will participate in the 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.
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.
Brief Title
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Categories
Completion Date
Completion Date Type
Actual
Conditions
Partial Epilepsy
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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
* 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.
Exclusion Criteria:
* 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
* 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
Inclusion Criteria
Inclusion Criteria:
* 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT01866111
Org Class
Industry
Org Full Name
SK Life Science, Inc.
Org Study Id
YKP3089C017
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Outcome Time Frame
baseline and 18 weeks
Secondary Outcomes
Outcome Description
Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period
Outcome Time Frame
18 weeks
Outcome Measure
50% Responder Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexis Boro
Investigator Email
aboro@montefiore.org