Accession Number:

AD1010685

Title:

Clobazam-Treated Patients with Lennox Gastaut Syndrome Experienced Fewer Seizure-Related Injuries than Placebo Patients During Trail OV-1012

Descriptive Note:

Journal Article

Corporate Author:

Lundbeck LLC Deerfield United States

Report Date:

2016-08-19

Pagination or Media Count:

4.0

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.

Subject Categories:

Distribution Statement:

APPROVED FOR PUBLIC RELEASE