title: Clobazam-treated patients with Lennox-Gastaut syndrome experienced fewer seizure-related injuries than placebo patients during trial OV-1012.
abstract: 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 (MedDRA) 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 AEs considered seizure-related were mild or moderate in intensity; 3 severe AEs 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.
authors.affiliation: Lundbeck LLC, Deerfield, Illinois, U.S.A.
authors.forename: Jouko
authors.initials: J
authors.lastname: Isojarvi
authors.affiliation: Lundbeck LLC, Deerfield, Illinois, U.S.A.
authors.forename: Deborah
authors.initials: D
authors.lastname: Lee
authors.affiliation: Lundbeck LLC, Deerfield, Illinois, U.S.A.
authors.forename: Guangbin
authors.initials: G
authors.lastname: Peng
authors.affiliation: Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Sperling
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects*; D001569:Benzodiazepines / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D000078306:Clobazam; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D004569:Electroencephalography; D005260:Female; D006801:Humans; D008607:Intellectual Disability; D007391:International Cooperation; D065768:Lennox Gastaut Syndrome / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam
keywords: Clobazam; Drop seizure; Injury; Lennox-Gastaut syndrome