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Evotec Reports Positive Top-Line Results in Phase II Study With EVT 201 in Elderly Insomniacs With Daytime Sleepiness
Date:10/16/2007

ndary PSG endpoints.

Parameter Placebo EVT 201 EVT 201

n=149 1.5 mg 2.5 mg

Adjusted mean TST (mins) / % 338.6 369.5 / 9% 395 / 17%

change from placebo

p=0.0001 p=<0.0001

Adjusted mean WASO (mins) / % 101.4 86.2 / 15% 65.3 / 36%

change from placebo

p=0.0140 p=<0.0001

Adjusted mean LPS (mins) / % 46.5 30.5 / 34% 26.5 / 43%

change from placebo

p=0.0091 p=0.0014

The PSG analysis also showed that EVT 201 generally preserved sleep architecture.

These PSG results were supported by patient reported measures including subjective Total Sleep Time (sTST), subjective Sleep Onset Latency (sSOL) and subjective Wake After Sleep Onset (sWASO).

Subjectively, sleep quality was improved on all nights and there was no residual sedation assessed 30-minutes post wake time (approximately 9 hours post dose).

An additional element of the study design was to assess daytime function on Day 8. This included the Multiple Sleep Latency Test (MSLT), an objective assessment of daytime sleepiness. Initial analyses showed that both doses of EVT 201 produced a statistically significant overall improvement in the MSLT compared to placebo, indicating that patients were less sleepy during the day following treatment with EVT 201.

Daytime function was further assessed objectively using the Rey Auditory Verbal Learning Test (RAVLT), a short-term verbal memory test, and Psychomotor Vigilance Task (PVT), a measure of sustained attention and reaction time and subjectively using the Karolinska Sleepiness Scale (KSS). Initial analyses suggest overall that there was no significant difference between EVT 201 and placebo. Further analyses of these endpoints are ongoing.

EVT 201 w
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SOURCE Evotec AG
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