SEE RESULTS FROM TWO XCOPRI CLINICAL TRIALS
XCOPRI® (cenobamate tablets) CV was studied across 2 multicenter, randomized, double-blind, placebo-controlled studies in adult patients with partial-onset seizures with or without secondary generalization1
concomitant antiseizure medications (ASMs) were not adequately controlling patients at baseline. The more frequently used ASMs were levetiracetam, lamotrigine, valproate or valproic acid, carbamazepine, oxcarbazepine, clobazam, lacosamide, and topiramate1-3
were taking 2 or more concomitant ASMs1
was the approximate
mean duration of
epilepsy for patients
in both studies1
was the median baseline seizure frequency for patients in both studies1
IN A STUDY OF ADULT PATIENTS WITH PARTIAL-ONSET SEIZURES TAKING XCOPRI® (CENOBAMATE TABLETS) CV:
2X GREATER SEIZURE REDUCTION WITH XCOPRI VS PLACEBO1
Median percentage reduction in 28-day seizure frequency
(18-week, double-blind period)
Study details on concomitant ASMs
Patients in the placebo arm remained on their current ASM(s)2,3
1-3 concomitant ASMs were not adequately controlling patients at baseline*
Percentage of patients who achieved seizure reductions of ≥50%, ≥75%, ≥90%, and 100%1,2
(12-week maintenance phase)
The efficacy of XCOPRI® (cenobamate tablets) CV as adjunctive therapy in partial-onset seizures was established in 2 multicenter, randomized, double-blind, placebo-controlled studies in adult patients (Study 1 and Study 2). Patients had partial-onset seizures with or without secondary generalization and were not adequately controlled with 1 to 3 concomitant ASMs. Study 1 [N=221] compared XCOPRI 200 mg/day with placebo. The double-blind treatment period consisted of a titration phase (6 weeks) and a maintenance phase (6 weeks for Study 1 and 12 weeks for Study 2). In both studies, patients were started on a higher starting dosage and/or faster titration than the Prescribing Information recommendation. The primary outcome was median percentage reduction in 28-day seizure frequency during the double-blind treatment period.
In Study 1, patients were started on a daily dosage of 50 mg (a higher starting dosage than currently recommended) and subsequently increased by 50 mg/day every 2 weeks, until the final daily target dosage of 200 mg/day was achieved. In Study 2, patients were started on a daily dosage increased by 50 mg/day every week (a faster titration than currently recommended) until 100 mg/day or 200 mg/day was reached and then increased by 100 mg/day every week in patients randomized to 400 mg/day.
Early Titration Data
Efficacy results observed within the first 4 weeks5
Once-daily XCOPRI is titrated at 2-week intervals.1 Learn more about dosing.
Post hoc analysis of an open-label safety study: Percentage of
patients who achieved seizure reductions of ≥50% during titration5
Nearly half of patients
had a ≥50% reduction in
seizures within the first
4 weeks of titration5
The most common treatment-emergent adverse events were
fatigue (35%), dizziness (32%), and somnolence (30%).
This post hoc analysis of an open-label study of XCOPRI® (cenobamate tablets) CV did not include a control arm.
These data are descriptive and representative of an enriched population with a relatively small number of patients.
Appropriate multiplicity adjustments were not applied.
A multicenter, open-label study evaluated the safety of XCOPRI® (cenobamate tablets) CV in 1340 adult patients with partial-onset seizures uncontrolled by 1 to 3 concomitant ASMs. The study included a screening period of up to 21 days and an open-label treatment period consisting of a 12-week titration phase followed by an open-label maintenance phase. The maintenance phase continued for the length of the study (total study duration up to 43 months). Patients initiated XCOPRI treatment using the FDA-approved titration schedule. After reaching 200 mg/day, further increases up to 400 mg/day using biweekly increments of 50 mg/day were allowed during the maintenance phase. Reductions below 200 mg were allowed at investigators’ clinical judgment (minimum allowed dose 50 mg/day). XCOPRI monotherapy was not allowed. Patient visits occurred every 2 weeks for 16 weeks and then every 1 to 3 months.
A post hoc analysis was conducted which evaluated the efficacy and safety of adjunctive XCOPRI in a subset of patients (n=240). To be eligible for the post hoc analysis, the following criteria must have been met: patients must have had at least one focal aware motor, focal impaired awareness, or focal or bilateral tonic-clonic seizure per 13 weeks baseline prior to screening visit; seizure data while on treatment; and consistent documentation of good-quality, raw, seizure data for ≥85% of the time spent in the study. Responder rates (≥50%, ≥75%, ≥90%, and 100% reduction in seizure frequency from baseline) were assessed during the entire treatment period, during the titration phase, and during the maintenance phase.
Read more about XCOPRI’s safety.