Efficacy Results
For the primary end point in Study C013, the cenobamate 200 mg group showed a median 55.6% reduction in partial seizure frequency per 28 days, compared with a 21.5% reduction in the placebo group (P < 0.0001). In Study C017, the median percent reduction in seizure frequency per 28 days was 55.0%, 55.0%, and 24.0% in the cenobamate 200 mg, 400 mg, and placebo groups, respectively (P < 0.001), favouring cenobamate versus placebo for both dosage groups.
For the responder analysis in Study C013, 50.4% of patients in the cenobamate 200 mg group and 22.2% of patients in the placebo group experienced at least a 50% reduction in seizure frequency during the DB treatment period (odds ratio [OR] = 3.94; 95% CI, 2.14 to 7.24; P < 0.0001; not controlled for type I error rate). In Study C017, 57.8%, 60.4%, and 21.7% of patients in the cenobamate 200 mg, 400 mg, and placebo groups, respectively, experienced at least a 50% reduction in seizure frequency per 28 days during the DB treatment phase. The analyses favoured the cenobamate groups versus placebo (both P < 0.001, not controlled for type I error rate). The alternate analyses, which were based on the treatment response in the maintenance period only, reported 56.1%, 64.2%, and 25.5% of patients experienced at least a 50% reduction in seizure frequency per 28 days in the cenobamate 200 mg, 400 mg, and placebo groups, respectively. For this alternate primary end point, the differences favoured the cenobamate 200 mg (P < 0.001) and 400 mg groups (P < 0.001) versus placebo.
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The proportion of patients who experienced at least a 75%, 90%, and 100% reduction in seizure frequency during the DB period and the maintenance period favoured the cenobamate 200 mg and 400 mg groups versus placebo; however, there was no control of type I error rate for these analyses in either study, and in Study C013, these analyses were conducted post hoc. While these results are generally supportive of the efficacy of cenobamate, the data should be interpreted in light of the potential inflated risk of type I error and risk of bias associated with post hoc analyses.
Of note, Study C017 also included a 100 mg cenobamate dosage group, which is half the Health Canada-recommended maintenance dose. The percent reduction in seizure frequency per 28 days and the proportion of patients who experienced at least a 50% reduction in seizure frequency both favoured the cenobamate 100 mg group versus placebo, but other secondary outcomes, such as the higher responder thresholds, failed to detect a difference between groups.
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HRQoL was not assessed in Study C013, and only descriptive data were available in Study C017 for approximately one-quarter of the patients enrolled. No meaningful change in HRQoL was observed in Study C017, based on data from the Quality of Life in Epilepsy Questionnaire (QOLIE-31-P).
Other outcomes of interest to patients, such as functional status, were not assessed, nor were seizure-free days or treatment retention, which were outcomes specified in the sponsor’s protocol.
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