Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453213
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-05
Brief Title:
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Sponsor:
SK Life Science Inc
Organization:
SK Life Science Inc
Study Overview
Official Title:
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cenobamate YKP3089 is a small molecule approved in the United States US Europe and several other countries around the world for the treatment of Partial-Onset focal seizures in adult subjects 18 years of age In the US it is approved for use as monotherapy however there is little clinical data assessing its use as monotherapy in adults with POS This study is designed to explore the effectiveness of doses of 100 mgday and 200 mgday as monotherapy in adult subjects with newly diagnosed or recurrent POSfocal onset epilepsy
Detailed Description:
This is an uncontrolled single-arm open-label Phase IV study conducted at approximately 40 sites in the US It will consist of the following Periods
1 Pretreatment Period up to 21 days
2 100 mgday Treatment Period 6-week Titration Phase 26-week Maintenance Phase
3 200 mgday Treatment Period 2-week Titration Phase 26-week Maintenance Phase
4 26-week Optional Extension Period
5 Follow Up Period 4 weeks
Pretreatment Period At the screening visit Visit 1 the investigator will obtain informed consent and assess the subject for their eligibility to participate in the study The investigator will review any available hematology chemistry blood tests and ECGs Vital signs and routine physical and neurological exam will be performed
100 mgday Treatment Period Subjects who complete screening and meet the inclusionexclusion criteria begin the 32-week Treatment Period which includes a 6-week Titration Phase and a 26-week Maintenance Phase During the Titration Phase subjects will be treated with cenobamate 125 mgday for two weeks 25 mgday for two weeks and 50 mgday for two weeks Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mgday in the Maintenance Phase for 26 weeks At the end of the Maintenance Phase the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate Subjects who experience a seizure during the 100 mgday Maintenance Phase with or without rescue medication use will transition to the 200 mgday Treatment Period
200 mgday Treatment Period The 200 mgday Treatment Period consists of a 2-week Titration Phase and a 26-week Maintenance Phase During the 2-week Titration Phase subjects will receive cenobamate 150 mgday before entering the 26-week 200 mgday Maintenance Phase At the end of the Maintenance Phase the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate If the subject experiences a seizure at 200 mgday during the Maintenance Phase then they will be discontinued from the study
Optional Extension Period
An Optional Extension Period will last 26 weeks During the Optional Extension Period Visits will occur at 13th week Day 315287a Visit 88a and 26th week Day 406378a Visit 99a to record vital signs and identify adverse events and occurrence of a seizure using a seizure diary If a seizure occurs during the Optional Extension Period the subject will be discontinued from the study
Follow-up Period
If a subject prematurely discontinues from the study is not continuing into the Optional Extension Period or completes the last visit in the Optional Extension Period cenobamate will be titrated down by 50 for two weeks and then discontinued A follow-up visit should occur two weeks after the date of cenobamate discontinuation
1 Pretreatment Period up to 21 days
2 100 mgday Treatment Period 6-week Titration Phase 26-week Maintenance Phase
3 200 mgday Treatment Period 2-week Titration Phase 26-week Maintenance Phase
4 26-week Optional Extension Period
5 Follow Up Period 4 weeks
Pretreatment Period At the screening visit Visit 1 the investigator will obtain informed consent and assess the subject for their eligibility to participate in the study The investigator will review any available hematology chemistry blood tests and ECGs Vital signs and routine physical and neurological exam will be performed
100 mgday Treatment Period Subjects who complete screening and meet the inclusionexclusion criteria begin the 32-week Treatment Period which includes a 6-week Titration Phase and a 26-week Maintenance Phase During the Titration Phase subjects will be treated with cenobamate 125 mgday for two weeks 25 mgday for two weeks and 50 mgday for two weeks Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mgday in the Maintenance Phase for 26 weeks At the end of the Maintenance Phase the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate Subjects who experience a seizure during the 100 mgday Maintenance Phase with or without rescue medication use will transition to the 200 mgday Treatment Period
200 mgday Treatment Period The 200 mgday Treatment Period consists of a 2-week Titration Phase and a 26-week Maintenance Phase During the 2-week Titration Phase subjects will receive cenobamate 150 mgday before entering the 26-week 200 mgday Maintenance Phase At the end of the Maintenance Phase the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate If the subject experiences a seizure at 200 mgday during the Maintenance Phase then they will be discontinued from the study
Optional Extension Period
An Optional Extension Period will last 26 weeks During the Optional Extension Period Visits will occur at 13th week Day 315287a Visit 88a and 26th week Day 406378a Visit 99a to record vital signs and identify adverse events and occurrence of a seizure using a seizure diary If a seizure occurs during the Optional Extension Period the subject will be discontinued from the study
Follow-up Period
If a subject prematurely discontinues from the study is not continuing into the Optional Extension Period or completes the last visit in the Optional Extension Period cenobamate will be titrated down by 50 for two weeks and then discontinued A follow-up visit should occur two weeks after the date of cenobamate discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None