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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01866111
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : April 29, 2022
Last Update Posted : April 29, 2022
Information provided by (Responsible Party):
SK Life Science, Inc.

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.

Condition or disease Intervention/treatment Phase
Partial Epilepsy Drug: YKP3089 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2013
Actual Primary Completion Date : April 5, 2021
Actual Study Completion Date : October 31, 2021

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: YKP3089 Low Dose
YKP3089 Low Dose
Drug: YKP3089
Experimental: YKP3089 Medium Dose
YKP3089 Medium Dose
Drug: YKP3089
Experimental: YKP3089 High Dose
YKP3089 High Dose
Drug: YKP3089

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 50% Responder Rate [ Time Frame: 18 weeks ]
    Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01866111

Show Show 67 study locations
Sponsors and Collaborators
SK Life Science, Inc.
  Study Documents (Full-Text)

Documents provided by SK Life Science, Inc.:
Study Protocol  [PDF] June 17, 2019
Statistical Analysis Plan  [PDF] May 15, 2021

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: SK Life Science, Inc. Identifier: NCT01866111    
Other Study ID Numbers: YKP3089C017
First Posted: May 31, 2013    Key Record Dates
Results First Posted: April 29, 2022
Last Update Posted: April 29, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations