Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879433
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2020-12-31
Brief Title:
Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Sponsor:
Mid-Atlantic Epilepsy and Sleep Center LLC
Organization:
Mid-Atlantic Epilepsy and Sleep Center LLC
Study Overview
Official Title:
Prospective Open Label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy a Real-world Experience Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
To evaluate the efficacy safety and tolerability of cenobamate as adjunctive treatment of refractory focal epilepsy
Detailed Description:
The purpose of the study is to evaluate efficacy and safety of adjunctive cenobamate treatment of adults with drug-resistant focal epilepsy in real world clinical setting providing real world experience to help guide future cenobamate treatment This will be an open label study comparing seizure frequency during 52 weeks of baseline observation period with seizure frequency during 52 weeks of adjunctive cenobamate maintanance treatment 100 adults aged 18-70 with severe refractory focal epilepsy with focal seizures that have failed to respond to 4 antiseizure drugs ASDs - respective surgery - vagal nerve stimulator VNS responsive nerve stimulator RNS or deep brain stimulator DBS treatment with epilepsy duration of 2 years and followed by the Investigator andor his epileptologist colleagues at the Investigators institution for 1 year will be enrolled Patients will be on ASDs deemed by the Investigator to have achieved the best seizure control to-date No more than 5 ASDs will be used VNS RNS and DBS will be allowed and not counted as an ASD However patients on VNS RNS or DBS will have to have had the device placed 6 months before study initiation and have had stable stimulator settings for 3 months Baseline will include 52 weeks of prospectively kept well documented seizure diaries that have been regularly prospectively reviewed by the treating epileptologist during 52 weeks prior to study initiation Retrospective review of these diaries will be allowed and count as baseline As an alternative to seizure diaries well-documented seizure frequency obtained during regular clinical visits reviewed by the treating epileptologist and documented in the patients chart during regular clinical visits during the 52 weeks baseline period will be allowed in lieu of seizure diaries ASDs will be held stable during the last month of baseline observation period Following a baseline of 52 weeks patients will be started on cenobamate administered orally in qhs qd or bid schedule Both starting dose and titration schedule up to initial target dose of 100-250 mg will follow FDA approved guidelines
Cenobamate target dose will range from 100-400 mgday Within this range the target dose will be individualized and will be the dose when seizure freedom intolerable TEAEs or 400 mgday is reached whichever occurs first Maintenance period will start when seizure freedom 250 mgday dose or maximum tolerated dose of 100 mgday is reached whichever comes first Maintenance treatment will last for 52 weeks Total treatment period may vary between subjects depending on titration and final dose but maintenance treatment period will be 52 weeks for all subjects During both titration and cenobamate treatment reduction of the dose of concomitant other ASDs will be allowed as clinically indicated increase in the dose of concomitant ASDs will not be allowed nor will initiation of any new antiseizure therapy other than cenobamate Initiation of new antiseizure treatment or clinically indicated need for increase of ASD other than cenobamate will end of the active part of the study although patients will be followed to the end of the 52 week maintenance treatment period
Cenobamate target dose will range from 100-400 mgday Within this range the target dose will be individualized and will be the dose when seizure freedom intolerable TEAEs or 400 mgday is reached whichever occurs first Maintenance period will start when seizure freedom 250 mgday dose or maximum tolerated dose of 100 mgday is reached whichever comes first Maintenance treatment will last for 52 weeks Total treatment period may vary between subjects depending on titration and final dose but maintenance treatment period will be 52 weeks for all subjects During both titration and cenobamate treatment reduction of the dose of concomitant other ASDs will be allowed as clinically indicated increase in the dose of concomitant ASDs will not be allowed nor will initiation of any new antiseizure therapy other than cenobamate Initiation of new antiseizure treatment or clinically indicated need for increase of ASD other than cenobamate will end of the active part of the study although patients will be followed to the end of the 52 week maintenance treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None