Abstract Details

Title Response to Clobazam in Relationship to Baseline Seizure Frequency

Topic Epilepsy

Presentation(s) P07 - (-)

Poster/Presentation
Number 176

Objective

Background BACKGROUND: LGS Patients differ in disease severity. AEDs should demonstrate efficacy for even the most severe patients.

Design/Methods DESIGN/METHODS: CONTAIN compared 3 oral dosages of clobazam with placebo as adjunctive therapy for LGS. Patients 2-60 years of age with LGS enrolled. Following a 4-week baseline, patients who had ?2 drop seizures per 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. Patients were grouped by quartile based on their average baseline weekly seizure frequencies. The low-, medium-, and high-dosage groups were combined for analysis.

Results RESULTS: 301 patients were screened, 238 were randomized, 217 comprised the modified, intention-to-treat population (efficacy analyses), and 177 completed the study. Each quartile had [sim]40 patients. Ranges (seizures/week) were: <10 (Quartile 1), 10-30 (Quartile 2), 32-86 (Quartile 3), and 86-1,077 (Quartile 4). Mean percentage decreases in average weekly seizures were similar for all quartiles for both drop and total seizures (drop plus non-drop seizures). >50% of patients in all 4 quartiles demonstrated ?50% decreases in weekly frequency for both drop and total seizures. Decreases in percentage of patients achieving 100% reductions in drop and total seizures were observed for patients with greater baseline seizure frequencies. However, 5% of patients in Quartile 4 (patients with most severe LGS) still achieved 100% reduction in drop seizures.

Conclusions CONCLUSIONS: Using baseline seizure counts as a surrogate for disease severity, we determined clobazam was efficacious even for patients with average weekly seizure counts at baseline up to 1,077 seizures/week, and a small percentage were still able to achieve freedom from drop seizures.

Authors/Disclosures
Jouko I. Isojarvi, MD, PhD (Lundbeck) PRESENTER	No disclosure on file
Deborah A. Lee, MD, PhD (AlaWai Neurology Consulting LLC)	No disclosure on file
	No disclosure on file

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