Abstract Details

Title Somnolence and Sedation Were Transient Adverse Events for Most Patients Receiving Clobazam Therapy during the CONTAIN Study in Lennox-Gastaut Syndrome (LGS)

Topic Epilepsy

Presentation(s) P04 - (-)

Poster/Presentation
Number 208

Objective

Background BACKGROUND: Somnolence and sedation are common adverse events related to treatment with benzodiazepines. It has been hypothesized that treatment with clobazam may be less frequently associated with these types of AEs than treatment with 1,4-benzodiazepines.

Design/Methods DESIGN/METHODS: The CONTAIN trial 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 phase, patients who had ?2 drop seizures per week were randomized to placebo or 1 of 3 dosages of clobazam (0.25, 0.5, and 1.0 mg/kg/day), up to a maximum daily dosage of 40 mg. Treatment included a 3-week titration phase, followed by a 12-week maintenance phase. The safety population included all who received ?1 dose of study drug or placebo. Incidence, time to onset, duration, and time to resolution of somnolence-related AEs (defined as somnolence and sedation) were analyzed for patients treated with placebo, or low-, medium-, or high-dosage clobazam.

Results RESULTS: The incidence of somnolence and/or sedation was greater for patients treated with clobazam (26%) than patients treated with placebo (15%). Further, the incidence increased with greater dosages of clobazam (low-dosage, 17%; medium-dosage, 27%; and high-dosage, 32%). For most patients, onset of these events was within the first 3 weeks of treatment (during titration). The majority of these events resolved (placebo, 73%; low-dosage, 82%; medium-dosage, 63%; and high-dosage, 83%). The median duration of these somnolence-related adverse events was within 2-3 weeks for all clobazam treatment groups.

Conclusions CONCLUSIONS: Somnolence and sedation were relatively common AEs observed during clobazam treatment in CONTAIN, and were dosage-related. However, most of these events were transient and resolved within a few weeks.

Authors/Disclosures
J Renfroe, MD (Child Neurology Center of Northwest Florida) PRESENTER	Dr. Renfroe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Engage Therapeutics. Dr. Renfroe has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Renfroe has received intellectual property interests from a discovery or technology relating to health care.
Jouko I. Isojarvi, MD, PhD (Lundbeck)	No disclosure on file
Deborah A. Lee, MD, PhD (AlaWai Neurology Consulting LLC)	No disclosure on file
Eric Klawiter, MD, FAAN (Massachusetts General Hospital)	Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Galen/Atlantica. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Banner Life Sciences. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Klawiter has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for OM1. Dr. Klawiter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Klawiter has received research support from Biogen. The institution of Dr. Klawiter has received research support from Abbvie. The institution of Dr. Klawiter has received research support from Genentech.

��ɫ��

��ɫ��