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

• ClinicalTrials.gov Identifier: NCT01397968
• Recruitment Status: Completed
• First Posted: July 20, 2011
• Results First Posted: April 11, 2022
• Last Update Posted: April 11, 2022
• Sponsor: SK Life Science, Inc.
• Information provided by (Responsible Party): SK Life Science, Inc.

Tracking Information

• First Submitted Date: July 18, 2011
• First Posted Date: July 20, 2011
• Results First Submitted Date: August 20, 2020
• Results First Posted Date: April 11, 2022
• Last Update Posted Date: April 11, 2022
• Actual Study Start Date: July 6, 2011
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2022)

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days [ Time Frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported ]

Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline

• Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (submitted: April 8, 2022)

50% Responder Rate [ Time Frame: 12 weeks ]

Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.

• Original Secondary Outcome Measures (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: Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Partial Epilepsy

Intervention

• Drug: YKP3089
  Capsule, dose to be titrated Tablet, dose to be titrated
  Other Name: cenobamate
• Drug: Placebo
  Placebo capsule Placebo tablet

Study Arms

• Experimental: YKP3089
  Intervention: Drug: YKP3089
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Publications *

• French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.
• Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2014): 222
• Original Estimated Enrollment (submitted: July 19, 2011): 200
• Actual Study Completion Date: January 28, 2021
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India, Korea, Republic of, Poland, United States

Administrative Information

• NCT Number: NCT01397968
• Other Study ID Numbers: YKP3089C013
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: SK Life Science, Inc.
• Original Responsible Party: Head Regulatory Affairs, SK Life Science Inc.
• Current Study Sponsor: SK Life Science, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Marc Kamin, MD; SK Life Science, Inc.

• PRS Account: SK Life Science, Inc.
• Verification Date: April 2022