The Phase II program is a multi-center, randomized, double-blind placebo- controlled study in patients with sleep maintenance insomnia (SMI). The primary endpoint is an assessment of objective slow wave sleep using polysomnography (PSG). Secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. Additionally, the study will make an assessment regarding next-day cognitive performance.
Sharon Mates, chairman and CEO of Intra-Cellular Therapies (ITI), said: “This drug candidate has therapeutic potential to treat SMI in the general population, and in other patient populations who have been underserved, particularly peri- and post-menopausal women, and in other disorders where insomnia is a problem.”