Abstract Details

Title Use of Rescue Medications by Lennox-Gastaut (LGS) Patients Treated with Clobazam during the CONTAIN Trial

Topic Epilepsy

Presentation(s) P01 - (-)

Poster/Presentation
Number 046

Objective

Background Clobazam was FDA-approved in October 2011 for LGS.

Design/Methods CONTAIN compared 3 dosages of clobazam with placebo as adjunctive LGS therapy. LGS patients 2-60 years of age 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, followed by a 12-week maintenance phase. The modified intention-to-treat (mITT) population included all patients who had ?1 daily seizure measurement during the maintenance phase. Patients were permitted 1 rescue/day, with no more than a total of 4 days in 4 weeks (average of 1 rescue dosage/week). If more rescue treatments were required, the patient was considered a treatment failure, discontinued, and tapered off study drug or enrolled in an OLE. Treatment options included, but were not limited to, medications such as rectal diazepam and lorazepam.

Results 301 patients were screened, 238 were randomized, 217 comprised the mITT population (efficacy analyses), and 177 completed the study. The percentage of patients who received rescue medications at least once during the study was <20% in all treatment groups and lower in each clobazam group than in the placebo group (differences not statistically significant). The numbers (percentages) were 7 (13.2), 5 (8.6), and 4 (8.2) for low-, medium-, and high-dosage clobazam, and 11 (19.3) for placebo.

Conclusions Rescue medications were used infrequently during the maintenance period of CONTAIN. There were no clinically important or statistically significant differences between treatment groups in the percentage of patients who employed rescue medications on multiple occasions. However, there was a trend toward less frequent use of rescue medications in the low-, medium- and high-dosage clobazam groups.

Authors/Disclosures
William E. Rosenfeld, MD, FAAN (Comprehensive Epilepsy Care Center for Children and Adults) PRESENTER	The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for SK Life Science.
Deborah A. Lee, MD, PhD (AlaWai Neurology Consulting LLC)	No disclosure on file
Jouko I. Isojarvi, MD, PhD (Lundbeck)	No disclosure on file
Sarah Naoshy	No disclosure on file

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