Study in Elderly Patients With Primary Insomnia and Daytime Sleepiness
HAMBURG, Germany and OXFORD, England, November 17 /PRNewswire-FirstCall/ -- Evotec AG announced today the initiation of a second Phase II study with EVT 201 under a US IND. This randomised, multi-centre, double-blind study is a parallel design study with two doses of EVT 201 and placebo in 135 elderly patients with chronic primary insomnia and day-time sleepiness. 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 Research & Development Officer at Evotec.
The primary endpoint of this second patient trial with EVT 201 is to assess "total sleep time" (TST) determined by polysomnography. The 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" (WASO) and number of awakenings, determined by polysomnography. 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 using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced "wake after sleep onset" (WASO) while significantly increasing "total sleep time" (TST) and quality of sleep with no subjective residual effects. The compound was well tolerated without significant adverse events.
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