Abstract Details

Title Response to Clobazam in VNS vs. Non-VNS Patients: Post-Hoc Subgroup Analyses of CONTAIN

Topic Epilepsy

Presentation(s) P04 - (-)

Poster/Presentation
Number 207

Objective

Background BACKGROUND: Lennox-Gastaut syndrome (LGS) patients differ by disease severity. Vagal nerve stimulation (VNS) is one treatment option for LGS patients.

Design/Methods DESIGN/METHODS: CONTAIN compared 3 oral dosages of clobazam with placebo as adjunctive LGS therapy. Patients 2-60 years of age with LGS enrolled. Following a 4-week baseline, patients who had ?2 drop seizures/week were randomized to placebo or 1 of 3 clobazam dosages (0.25, 0.5, and 1.0 mg/kg/day), ?40 mg/day maximum. Treatment included a 3-week titration phase, followed by a 12-week maintenance phase. The mITT analysis included all patients who had ?1 daily seizure measurement during maintenance therapy. Patients were grouped by whether they were receiving or not receiving VNS treatment during the study. All clobazam dosage groups were combined.

Results RESULTS: Both VNS and non-VNS groups experienced significant mean percentage decreases in average weekly drop and total seizure (drop plus non-drop) rates vs. placebo. Least-square mean percentage decreases in average weekly rate of drop and total seizures (mITT population) were 51.7 and 47.9 for VNS patients receiving clobazam (vs. -21.5 and -5.8 for placebo, p<0.01). For non-VNS patients, these percentages were 53.3 and 47.9 for clobazam (vs. 25.9 and 15.4 for placebo, p<0.01). >50% of clobazam patients in both the VNS and non-VNS groups demonstrated ?50% decreases in average weekly drop and total seizure frequencies, and >10% of clobazam-treated patients in both groups achieved drop-seizure-freedom.

Conclusions CONCLUSIONS: Clobazam provided similar efficacy in improving rates of drop and total seizures for LGS patients, regardless of whether they were receiving VNS treatment or not. These results suggest clobazam is efficacious not only for less severe LGS patients, but also for more refractory LGS patients.

Authors/Disclosures
Selim R. Benbadis, MD, FAAN (University of South Florida) PRESENTER	Dr. Benbadis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Stratus. Dr. Benbadis has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Lifesciences. Dr. Benbadis has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Benbadis has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Catalyst. Dr. Benbadis has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurelis. Dr. Benbadis has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Benbadis has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Livanova. Dr. Benbadis has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB.
Gretchen A. Ayer, MS	No disclosure on file
Jouko I. Isojarvi, MD, PhD (Lundbeck)	No disclosure on file
Deborah A. Lee, MD, PhD (AlaWai Neurology Consulting LLC)	No disclosure on file
Damian A. Gasparotto, PharmaD (Biogen Idec)	No disclosure on file

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