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- Title
Clobazam-treated patients with Lennox-Gastaut syndrome experienced fewer seizure-related injuries than placebo patients during trial OV-1012.
- Authors
Isojarvi, Jouko; Lee, Deborah; Peng, Guangbin; Sperling, Michael R.
- 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 (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 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.
- Subjects
LENNOX-Gastaut syndrome; WOUNDS &; injuries; SEIZURES (Medicine); PLACEBOS; MEDICAL care
- Publication
Epilepsia (Series 4), 2016, Vol 57, Issue 6, pe113
- ISSN
0013-9580
- Publication type
Article
- DOI
10.1111/epi.13388