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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by SK Life Science
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01866111
First received: May 28, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866111

Contacts
Contact: P. Ilankumaran, PhD 201-421-3810 pilan@sk.com

  Show 71 Study Locations
Sponsors and Collaborators
SK Life Science
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT01866111     History of Changes
Other Study ID Numbers: YKP3089C017
Study First Received: May 28, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 25, 2014