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Summary  Drop seizures are especially problematic in patients with Lennox‐Gastaut syndrome ( LGS ) because of their potential for serious injury. In this post hoc analysis of phase 3  OV ‐1012 data, a medical review was conducted of seizure‐related injuries based on Medical Dictionary for Regulatory Activities (Med DRA ) preferred terms from all adverse event ( AE ) listings. Patients receiving clobazam experienced fewer seizure‐related injuries than those receiving placebo (8.9% all clobazam dosages vs. 27.1% placebo, p ≤ 0.05). Significant differences in the rates of seizure‐related injuries were observed for the medium‐ and high‐dosage clobazam treatment groups (4.8% and 10.2%, respectively, p ≤ 0.05). A total of 50 of 53  AE s considered seizure‐related were mild or moderate in intensity; 3 severe  AE s occurred in the placebo group (fall, contusion, and jaw fracture). A single serious  AE  (jaw fracture, which required hospitalization and surgery) occurred in a placebo‐treated patient. Most injuries resolved by the end of the study. This analysis indicates that the reduction in drop‐seizure frequency achieved with clobazam provides a clinically meaningful benefit, a reduced likelihood of experiencing seizure‐related injuries.

Clobazam‐treated patients with Lennox‐Gastaut syndrome experienced fewer seizure‐related injuries than placebo patients during trial OV ‐1012