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Trial record 4 of 41 for:    sk life science

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
SK Life Science Identifier:
First received: May 28, 2013
Last updated: October 12, 2016
Last verified: October 2016

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 Intervention Phase
Partial Epilepsy
Drug: YKP3089
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Percent reduction in seizure frequency (average 28-day seizure rate) of complex partial and/or secondarily generalized and/or simple partial motor seizures during the double-blind phase relative to the pretreatment baseline. [ Time Frame: 18 weeks ]

Secondary Outcome Measures:
  • The response to treatment, defined as a 50% or greater reduction during the double blind phase in the seizure frequency from baseline for the ITT subjects. [ Time Frame: 18 weeks ]

Enrollment: 437
Study Start Date: July 2013
Estimated Study Completion Date: December 2018
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01866111

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Sponsors and Collaborators
SK Life Science
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SK Life Science Identifier: NCT01866111     History of Changes
Other Study ID Numbers: YKP3089C017
Study First Received: May 28, 2013
Last Updated: October 12, 2016

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on April 24, 2017