Evotec starts mid-stage insomnia trial

It is designed to assess the hypnotic efficacy of EVT 201 during seven nights’ treatment and also to determine 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 Dr John Kemp, chief R&D officer at Evotec.

The primary endpoint of this second patient trial with EVT 201 is to assess total sleep time. The secondary endpoints include a variety of tests of daytime sleepiness and functional performance as well as additional sleep efficacy measures. In addition, effects on sleep architecture will be examined and patients will evaluate sleep quality and quantity subjectively.

In September 2006, Evotec initiated its first phase II clinical trial with EVT 201 which is ongoing. Prior to this, in two phase I/II studies EVT 201 significantly reduced “wake after sleep onset” while significantly increasing “total sleep time” and quality of sleep with no subjective residual effects. The compound was well tolerated without significant adverse events.