Evotec AG initiates second Ph II EVT 201 trial

German drugmaker Evotec AG has initiated a second Phase II trial with EVT 201, its candidate insomnia drug. This randomized, multicenter, parallel-design, double-blind study will assess two doses of EVT 201 and placebo in 135 elderly patients with chronic primary insomnia and day-time sleepiness, evaluating the agent's hypnotic efficacy during seven nights' treatment as well as determining the effect of improved sleep quality on daytime performance.

"The elderly are a significant portion of the insomnia patient population. This study allows us to get early data on the efficacy of EVT 201 in this important patient group which we believe could provide us with a competitive edge," commented John Kemp, Evotec's chief R&D officer.

The primary endpoint of the total sleep time will be determined by polysomnography while secondary endpoints include a variety of tests of daytime sleepiness and functional performance as well as additional sleep efficacy measures such as latency to persistent sleep, wake after sleep onset and number of awakenings, determined by polysomnography. In addition, effects on sleep architecture will be examined and patients will subjectively evaluate sleep quality and quantity.