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- W2275764539 abstract "OBJECTIVE: This post-hoc subanalysis of the Phase III CONTAIN trial evaluated the incidence and time to resolution of somnolence and sedation for patients with LGS. 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: 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: 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: 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. Supported by: Lundbeck LLC. Disclosure: Dr. Renfroe has received research support from Lundbeck Research USA. Dr. Isojarvi has received personal compensation for activities with Lundbeck as an employee. Dr. Lee has received personal compensation for activities with the Foundation for Peripheral Neuropathy as an advisory board member.Dr. Lee has received personal compensation for activities with Lundbeck as an employee. Dr. Lee hold stock and stock options in Baxter." @default.
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- W2275764539 date "2013-02-12" @default.
- W2275764539 modified "2023-09-26" @default.
- W2275764539 title "Somnolence and Sedation Were Transient Adverse Events for Most Patients Receiving Clobazam Therapy during the CONTAIN Study in Lennox-Gastaut Syndrome (LGS) (P04.208)" @default.
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