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Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant 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: NCT01397968
Recruitment Status : Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
SK Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE July 18, 2011
First Posted Date  ICMJE July 20, 2011
Last Update Posted Date November 5, 2019
Study Start Date  ICMJE May 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
Percent change in seizure frequency per 28 days in the Treatment Period compared to the Baseline in the Intention to Treat (ITT) Population. [ Time Frame: per 28 days during 12 week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
Responder rate: analysis of subjects who experience a 50% or greater reduction in seizure frequency in the Treatment Period of the Double-blind Phase. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
Responder rate: An analysis of subjects who experience a 50% or greater reduction in seizure frequency in the Treatment Period of the Double-blind Phase. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Official Title  ICMJE A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Brief Summary

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.

Also to evaluate the safety and tolerability of YKP3089.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Partial Epilepsy
Intervention  ICMJE
  • Drug: YKP3089
    Capsule, dose to be titrated Tablet, dose to be titrated
    Other Name: cenobamate
  • Drug: Placebo
    Placebo capsule Placebo tablet
Study Arms  ICMJE
  • Experimental: YKP3089
    Intervention: Drug: YKP3089
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 17, 2014)
222
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2011)
200
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of treatment resistant partial epilepsy;
  • History of epilepsy for at least 2 years;
  • Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
  • Currently treated on a stable dose of :

    • 1 - 3 AED's for at least 12 weeks prior to randomization.
    • VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
    • Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

  1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
  2. Subject has had status epilepticus within past 1 year.
  3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
  4. Subjects taking felbamate with less than 18 months continuous exposure.
  5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
  6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
  7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
  8. Subject meets criteria for current major depressive episode (within 6 months).
  9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 India,   Korea, Republic of,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01397968
Other Study ID Numbers  ICMJE YKP3089C013
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
Study Director: Marc Kamin, MD SK Life Science, Inc.
PRS Account SK Life Science, Inc.
Verification Date October 2019

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