Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01866111
Recruitment Status : Unknown
Verified September 2019 by SK Life Science, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2013
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
SK Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date September 20, 2019
Study Start Date  ICMJE July 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Partial Epilepsy
Intervention  ICMJE
  • Drug: YKP3089
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: YKP3089 Low Dose
    YKP3089 Low Dose
    Intervention: Drug: YKP3089
  • Experimental: YKP3089 Medium Dose
    YKP3089 Medium Dose
    Intervention: Drug: YKP3089
  • Experimental: YKP3089 High Dose
    YKP3089 High Dose
    Intervention: Drug: YKP3089
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 21, 2015)
437
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2013)
400
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Czechia,   France,   Germany,   Hungary,   Israel,   Korea, Republic of,   Poland,   Romania,   Serbia,   Spain,   Thailand,   Ukraine,   United States
Removed Location Countries Czech Republic,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01866111
Other Study ID Numbers  ICMJE YKP3089C017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SK Life Science, Inc.
Study Sponsor  ICMJE SK Life Science, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SK Life Science, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP