Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01397968
First received: July 18, 2011
Last updated: March 11, 2013
Last verified: March 2013

July 18, 2011
March 11, 2013
May 2011
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01397968 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
A Phase 2 Multicenter, Double-Blind, Randomized, Adjunctive Placebo Controlled Trial to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Partial Epilepsy
  • Drug: YKP3089
    Capsule, dose to be titrated
  • Drug: Placebo
    Placebo capsule
  • Experimental: YKP3089
    Intervention: Drug: YKP3089
  • Placebo Comparator: Placebo
    Placebo capsule
    Intervention: Drug: Placebo
Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
July 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Korea, Republic of,   Poland
 
NCT01397968
YKP3089C013
Yes
SK Life Science
SK Life Science
Not Provided
Principal Investigator: Pavel Klein, MB Mid-Atlantic Epilepsy and Sleep Center
SK Life Science
March 2013

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