The safety and efficacy of clobazam monotherapy in patients with new-onset focal or generalized seizures was investigated in a new Cochrane systematic review.

Researchers searched various databases to identify trials that compared clobazam monotherapy to placebo or another antiepileptic drug in patients with ≥2 unprovoked seizures or a single acute symptomatic seizure requiring short-term continuous treatment. Retention time, defined as time on allocated treatment, was set as the primary outcome, while short- and long-term efficacy, tolerability, quality of life, and tolerance measures were considered secondary outcomes.

The researchers identified 3 studies that met the inclusion criteria (N=206), however none of the trials reported on the selected primary outcome. “Lack of detail regarding allocation concealment and a high risk of performance and detection bias in 2 studies prompted us to downgrade the quality of evidence (by using the GRADE approach) for some of our results due to risk of bias,” the authors noted.

Related Articles

Results showed that there was no statistically significant difference between clobazam and carbamazepine treatment with regard to retention at 12 months (risk ratio [RR] 0.83, 95% CI, 0.61–1.12; low-quality evidence). Treatment with clobazam was associated with slightly better retention when compared with phenytoin, but this finding was backed by low-quality evidence (RR 1.43, 95% CI, 1.08–1.90). Moreover, there was insufficient evidence to determine whether patients were less likely to discontinue treatment with clobazam vs phenytoin due to side effects. (RR 0.10, 95% CI, 0.01–1.65; low-quality evidence).

“At present, there is insufficient evidence to inform clinical practice regarding clobazam monotherapy in focal or generalized seizures,” concluded the authors, adding “There is a definite need for well-designed, adequately powered, randomized controlled trials of clobazam monotherapy in people with new-onset/untreated seizures.”

For more information visit