Abstract | PURPOSE: METHODS: An exploratory post-hoc analysis of a randomized, double-blind, placebo-controlled clinical study (YKP3089C017) was conducted. Baseline concomitant ASMs were grouped as either those that employed an SCB or non-SCB MoA. Efficacy was examined by cenobamate dose (100 mg, 200 mg, and 400 mg/day) and concomitant ASM group using responder rates (≥50%, ≥75%, ≥90% seizure reduction; 100% seizure reduction/seizure freedom) during the maintenance phase and median percentage seizure reduction during the double-blind period. Treatment-emergent adverse events (TEAEs) were examined in the double-blind period. RESULTS: When co-administered with SCBs or non-SCBs, significantly higher percentages of patients achieved ≥50%, ≥75%, and ≥90% responder rates with cenobamate 200 mg/day and/or 400 mg/day versus placebo. Additionally, significantly higher percentages of patients achieved seizure freedom with cenobamate 400 mg/day versus placebo (SCB group, 17.5% versus 1.2%; non-SCB group, 40.0% versus 0.0%). Patients receiving 200 mg/day and 400 mg/day and concomitant SCBs and all patients taking cenobamate combined with non-SCB concomitant ASMs had significantly greater median percentage reductions in focal seizure frequency versus placebo. TEAEs were similar across groups; however, dizziness was more frequently reported in the SCB group. CONCLUSION:
Cenobamate is a highly effective new treatment option for patients with uncontrolled focal seizures when co-administered with SCB or non-SCB ASMs.
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Authors | Christian Brandt, Juan Carlos Sánchez-Álvarez, Bernhard J Steinhoff, Ivan Milanov, Jose M Serratosa |
Journal | Seizure
(Seizure)
Vol. 96
Pg. 86-93
(Mar 2022)
ISSN: 1532-2688 [Electronic] England |
PMID | 35168142
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2022. Published by Elsevier Ltd. |
Chemical References |
- Anticonvulsants
- Carbamates
- Chlorophenols
- Tetrazoles
- Cenobamate
|
Topics |
- Anticonvulsants
(adverse effects)
- Carbamates
(adverse effects)
- Chlorophenols
(adverse effects)
- Double-Blind Method
- Drug Therapy, Combination
- Humans
- Tetrazoles
- Treatment Outcome
|