What does this research mean for the field?

Adjunctive cenobamate provides sustained long-term efficacy, including a 25.5% complete seizure-free rate, and maintains a safe tolerability profile in adult Asian patients with uncontrolled focal seizures. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

To evaluate the long-term efficacy, safety, and tolerability of adjunctive cenobamate in patients with uncontrolled focal seizures participating in an open-label extension study.

August 30, 2026EpilepsiaOpen Access

Long‐term efficacy of adjunctive cenobamate: Open‐label extension of a randomized, placebo‐controlled study in a multinational Asian population

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Authors

SLSang Kun LeeSeoul National University Hospital PYPaul N. YuFudan University ECEunyeong ChoeSino Biopharmaceutical (China)

Discussion

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Implication

Randomized double-blind trial extension demonstrates sustained seizure reduction with adjunctive cenobamate in focal epilepsy, supporting long-term therapeutic utility.

Key Points

To evaluate the long-term efficacy, safety, and tolerability of adjunctive cenobamate in patients with uncontrolled focal seizures participating in an open-label extension study.
Conducted a 52-week multinational open-label extension following a randomized, double-blind, placebo-controlled trial (NCT04557085) in patients aged 18–70 years with uncontrolled focal seizures taking 1–3 antiseizure medications (n = 410 entered extension).
Patients underwent a 20-week conversion phase to cenobamate 400 mg/day followed by a 32-week open-label maintenance phase starting at 300 mg/day.
During the 32-week maintenance phase (n = 357), median focal seizure frequency decreased by 83.6% from baseline, with 75.1% achieving a ≥50% response and 25.5% achieving a 100% response (complete seizure freedom).
Overall, 84.6% of patients (347/410) completed 52 weeks of cenobamate treatment; serious treatment-emergent adverse events occurred in 11.7% (48/410), with zero deaths and zero cases of drug reaction with eosinophilia and systemic symptoms.

Cite This Study

Lee et al. (2026) studied this question.

synapsesocial.com/papers/6a93f07a6c1a8fb52e79ca9e https://doi.org/10.1002/epi.70459

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Implication

Randomized double-blind trial extension demonstrates sustained seizure reduction with adjunctive cenobamate in focal epilepsy, supporting long-term therapeutic utility.

Long‐term efficacy of adjunctive cenobamate: Open‐label extension of a randomized, placebo‐controlled study in a multinational Asian population

Discussion

Member takes

Implication

Key Points

Cite This Study

Long‐term efficacy of adjunctive cenobamate: Open‐label extension of a randomized, placebo‐controlled study in a multinational Asian population

Discussion

Member takes

Implication

Key Points

Cite This Study

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