Abstract Details

Title Treatment-Emergent Adverse Events (TEAEs) by Age for Patients with Lennox-Gastaut Syndrome (LGS) Treated with Clobazam during Phase II/III Trials

Topic Epilepsy

Presentation(s) P05 - (-)

Poster/Presentation
Number 096

Objective

Background BACKGROUND: In Phase II (OV-1002) and Phase III (CONTAIN) studies, clobazam significantly decreased average weekly frequencies of drop and total seizures associated with LGS. AEs were as expected, given clobazam's profile from clinical development efforts.

Design/Methods DESIGN/METHODS: In the Phase II trial, following a 4-week baseline, LGS patients were randomized to 1 of 2 clobazam dosages (0.25 and 1.0 mg/kg/day). Treatment included a 3-week titration period, followed by a 4-week maintenance period. CONTAIN compared 3 oral dosages of clobazam with placebo as adjunctive therapy for LGS. 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). Treatment included a 3-week titration, followed by a 12-week maintenance phase. The safety population included all who received ?1 dose of study drug or placebo. We evaluated safety results from baseline to maintenance phase in each trial for patients ?2 to <12 years of age; patients ?12 to <16 years; and patients ?16 years.

Results RESULTS: In the Phase II study, 68 patients were randomized and comprised the safety population. In CONTAIN, 238 were randomized and comprised the safety population, and 177 completed the study. For overall incidence of TEAEs and lab values, no notable clinically important differences between age groups were observed. Patients (%s) with ?1 TEAE were 174 (90.6), 43 (84.3), and 53 (94.6) for those ?2 to <12 years of age (n=192), ?12 to <16 years of age (n=51), and ?16 years of age (n=56), respectively.

Conclusions CONCLUSIONS: From pooled clobazam results, we observed no clinically important differences in TEAEs and laboratory values for LGS patients categorized by age.

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
Jeffrey R. Buchhalter, MD, FAAN (Buchhalter Consulting PLLC)	Dr. Buchhalter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Epilepsy Foundation. Dr. Buchhalter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Epilepsy Study Consortium. Dr. Buchhalter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Buchhalter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex. Dr. Buchhalter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Buchhalter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biocodex. Dr. Buchhalter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurona.
Christoph Thalheim (EMSP aisbl)	No disclosure on file

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