Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597084
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Anti-epileptogenic Effects of Eslicarbazepine Acetate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Epilepsy in Stroke Patients at High Risk of Developing Unprovoked Seizures Anti-epileptogenic Effects of Eslicarbazepine Acetate
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess if eslicarbazepine acetate ESL treatment started within 96 hours after stroke occurrence and continued for 30 days changes the incidence of unprovoked seizures USs within the first 6 months after randomisation as compared to placebo
Detailed Description:
This is a multicentre double-blind randomised placebo-controlled parallel-group trial in patients with acute intracerebral haemorrhage with a CAVE score 3 or an acute ischaemic stroke with a SeLECT score 6
At the first visit screeningbaseline V1a patients will undergo several examinations to check eligibility The next visit V1b has to be performed within 96 hours after primary stroke occurrence After eligibility has been confirmed patients will be randomised randomisation ratio 11 to treatment with ESL 800 mg Group A or placebo Group B
Patients will start treatment with the investigational medicinal product IMP ie ESL or placebo within 96 hours after primary stroke occurrence at V1b They will continue treatment until Day 30 after randomisation and then be tapered off Thereafter patients will be followed up until 18 months after randomisation Patients can concomitantly receive antiepileptic therapies except commercially available ESL or oxcarbazepine until Day 30
Concomitant antiepileptic therapies have to be discontinued and down-titration has to be started according to the respective Summary of Product Characteristics SmPC If the antiepileptic drugs AEDsbenzodiazepine are not already discontinued before downtitration must be started on Day 31 at the latest
If one or more ASs occurs within 7 days after primary stroke this will not result in change of IMP dose Patients having a first US will discontinue IMP treatment and will be treated at the discretion of the investigator until 18 months after randomisation except with commercially available ESL
Further visits will be performed 7 days V2 on-site 37 days V3 on-site 12 weeks V4 telephone 26 weeks V5 on-site 38 weeks V6 telephone 52 weeks V7 on-site 64 weeks V8 telephone and 78 weeks End of Trial EoT visit on-site after V1b
At the first visit screeningbaseline V1a patients will undergo several examinations to check eligibility The next visit V1b has to be performed within 96 hours after primary stroke occurrence After eligibility has been confirmed patients will be randomised randomisation ratio 11 to treatment with ESL 800 mg Group A or placebo Group B
Patients will start treatment with the investigational medicinal product IMP ie ESL or placebo within 96 hours after primary stroke occurrence at V1b They will continue treatment until Day 30 after randomisation and then be tapered off Thereafter patients will be followed up until 18 months after randomisation Patients can concomitantly receive antiepileptic therapies except commercially available ESL or oxcarbazepine until Day 30
Concomitant antiepileptic therapies have to be discontinued and down-titration has to be started according to the respective Summary of Product Characteristics SmPC If the antiepileptic drugs AEDsbenzodiazepine are not already discontinued before downtitration must be started on Day 31 at the latest
If one or more ASs occurs within 7 days after primary stroke this will not result in change of IMP dose Patients having a first US will discontinue IMP treatment and will be treated at the discretion of the investigator until 18 months after randomisation except with commercially available ESL
Further visits will be performed 7 days V2 on-site 37 days V3 on-site 12 weeks V4 telephone 26 weeks V5 on-site 38 weeks V6 telephone 52 weeks V7 on-site 64 weeks V8 telephone and 78 weeks End of Trial EoT visit on-site after V1b
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None