Abstract title

Trial details

Efficacy

Safety

Long-term outcomes with adjunctive Cenobamate by concomitant antiseizure medication

P2, NCT01866111, open-label extension, N=437, PCD: Jul’15, Active, not recruiting

Reduction in seizure frequency increased over the OLE, up to a median of 76.1% vs 72.5%-75.5% with other ASMs alone

Most common AEs for levetiracetam, lamotrigine, and lacosamide-treated patients: dizziness (19.0%, 19.4%, 18.8%), somnolence (9.6%, 12.0%, 14.4%), fatigue (5.7%, 6.6%, 11.4%), and diplopia (6.8%, 11.1%, 10.9%) (Source)

Seizure Reduction With Adjunctive Cenobamate (Post-hoc analysis) (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240, 177 remained on Cenobamate; (60/177) 33.9% patients experienced 100% seizure reduction for ≥12 months, Reduction in 28-day seizure frequency was 65.1% (12.5 mg/day), 77.9% (25 mg/day), and 100% (50 mg/day)

Common adverse events in ongoing Cenobamate patients were fatigue, dizziness, and somnolence. No cases of DRESS occurred

Adjunctive Cenobamate Dose in Seizure-Free Patients (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240; 33.9%patients experienced 100% seizure reduction for ≥12 months, mean dose in these patients was 236.0 mg/day

Dose adjustments impact on efficacy and tolerability (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240 and 177 remained on Cenobamate; Patients who remained on Cenobamate had greater dose reductions in concomitant clobazam (38.0 mg to 12.7 mg) vs those who discontinued Cenobamate (35.6 mg to 24.4 mg)

Efficacy of Cenobamate by concomitant antiseizure medication (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240 and 177 remained on Cenobamate; 60 patients had 100% seizure reduction ≥12 months at last visit most of the patients were on concomitant levetiracetam (43.3%) or zonisamide (21.7%) and clobazam (10.0%), Lamotrigine (27.1% to 28.6%)

Concomitant ASMs were decreased most often for AEs like dizziness, ataxia diplopia, sleepiness/somnolence, cognitive dysfunction, irritability fatigue.

Impact of dose adjustments to concomitant lamotrigine and carbamazepine on efficacy and tolerability (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240 and 177 remained on Cenobamate; 58.3% on lamotrigine and 68.8% on carbamazepine patients had their ASM dose reduced; 33.9% Cenobamate patients were seizure-free for ≥12 months and 28.3% received lamotrigine and 5.0% received carbamazepine

Among ongoing Cenobamate patients, lamotrigine and carbamazepine were discontinued in n=7 (14.5%) and n=5 (31.3%) patients mostly due to AEs

Impact of dose adjustments to concomitant ASMs on tolerability and retention (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240 and 177 remained on Cenobamate; Responder rates over the maintenance phase (~27 months) population were 75.7% for ≥50% reduction, 57.5% for ≥75% reduction, and 13.6% for 100% reduction.

High retention rates and numbers of seizure-free patients for prolonged periods (25.8% of the analysis population and 33.9% of the ongoing population had zero seizures for a mean of 23.5 months at last visit)

Among ongoing Cenobamate patients, 98/395 (24.8%) concomitant baseline ASMs was discontinued completely. Dose decreases were mostly due to adverse events

Efficacy of Cenobamate for Uncontrolled Focal Seizures (Post-hoc analysis) (Source)

P3, NCT02535091, open-label Safety and PK study, N=1345, PCD: Dec’20, Active, not recruiting

N=240 and 25.8% (62/240) had 100% seizure reduction for ≥12 months at the last visit, and 36.3% (87/240) had 100% seizure reduction for ≥12 months at any visit. High rates of sustained 100% seizure reduction (≥12 months) were achieved with Cenobamate in this post-hoc analysis from the long-term open-label study

The most common adverse events among all patients included fatigue, dizziness, and somnolence