Investigational AED Show Promise in Two Randomized Trials
VANCOUVER, BC—Seizure-free rates for new investigational antiepileptic drug (AED), YKP3089, were improved by almost 20% compared to placebo in a randomized clinical trial, according to study results at the 68th AAN Annual Meeting.
Two separate trials were conducted to test different levels of dosage. Each participant had >3 seizures/28 days during 8 weeks at baseline, despite treatment with 1–3 AEDs. They were randomized into the YKP3089 group or placebo group.
In the first trial, C013, 109 and 113 patients were randomized to placebo or YKP3089 200mg/day, respectively. This trial lasted for 6 weeks and results showed seizure-free rates in the YKP3089 group to be 28% vs. 9% for the placebo group.
The second trial, C017, lasted for 12 weeks and 108, 110, and 111 patients were randomized to YKP3089 100mg, 200mg, and 400mg/day arms, respectively, with 108 randomized to placebo. YKP3089 100mg, 200mg, and 400mg produced seizure-free rates of 3%, 11% (P=0.004), and 20% (P<0.001), respectively, compared to 1% with placebo.
"YKP3089 at 200mg and 400mg was highly effective vs. placebo in achieving seizure freedom,” said lead author Gregory Krauss, MD, from Johns Hopkins University, Baltimore, MD. However, he pointed out that, “further research must be conducted to determine the durability of our findings.”
Disclosure: Each author has consulted for, or is an employee of, SK Life Science.