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| |  Carisbamate Effective, Well Tolerated for the Treatment of Partial-Onset Seizures: Presented at AES By John Otrompke BOSTON -- December 9, 2009 -- An experimental drug being developed for the treatment of partial-onset seizures is effective and well tolerated in extended use, according to a study presented here December 6 at the American Epilepsy Society (AES) 63rd Annual Meeting. In the study, 1,008 patients out of the 1,127 who had been randomised to the initial 12 week double-blind trial were admitted to the open-label extension. At the time of data cut-off, 53.6% of 870 patients who had been followed for 18 months or longer had completed at least 18 months of treatment. The median reduction in the frequency of partial-onset seizures was 41.4% at 18 months and about 42% of patients were responders, defined as having a reduction in seizures by at least 50%. Of the 1008 patients, 48 (4.8%) remained seizure-free during the last 6 months of study treatment. “When patients finished the double-blind trial, most started at 400 mg/day immediately,” said Gerald Novak, MD, Johnson and Johnson Pharmaceutical Research and Development, Raritan, New Jersey. During the first 6 months, 66% of patients took 400 mg/day or less, while 33% took between 400 and 800 mg. During months 7 through 12, 51% of patients took 400 mg/day or less, while 49% took between 400 and 800 mg. During the final 6 months, the numbers were 49% and 50%, respectively. Two deaths occurred while patients were receiving carisbamate, but both were considered unrelated to drug treatment. One was due to head injury and the other was due to drowning. An additional 3 deaths were reported, but patients had already discontinued from the study. One death was due to trauma (considered not related to treatment), the other due to renal failure, which occurred 1 day after the last dose of carisbamate, and the third death was due to hepatic metastases of unknown etiology which occurred 172 days after the last dose of carisbamate. “We’re pretty sure the renal failure was unrelated; the person definitely had other reasons for kidney failure, and we had pre-existing evidence of it,” said Dr. Novak. The researchers found some occasional cases of rash among study participants, but the cases were too rare to report, according to Dr. Novak. In addition, there were no reported cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. The incidence of treatment-emergent adverse events was low during the first 18 months, with headache and dizziness being the most commonly reported adverse events. Funding for this study was provided by Johnson and Johnson. [Presentation title: An Open-Label Extension of Two Placebo-Controlled Studies of Carisbamate as Adjunctive Treatment of Partial Onset Seizures in Adults: 18-Month Update. Abstract 1.127]
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