Very Robust Findings on the Key Problems Faced by Insomniacs, i.e. Sleep Onset and Sleep Maintenance
Evotec to Host a Conference Call Today at 11:00 am CET (10:00 am UK time, 5:00 am EST, 7:00 pm AEST) Directly From the Worldsleep07 Congress in Australia
HAMBURG, Germany and OXFORD, England, September 5 /PRNewswire-FirstCall/ -- Evotec AG (Frankfurt Stock Exchange: EVT) presented today at the worldsleep07 congress in Cairns, Australia the details of the results from its first Phase II clinical trial of EVT 201 in patients with primary insomnia. EVT 201 is a partial positive allosteric modulator (pPAM) of the GABAA receptor complex. The double-blind, placebo controlled cross-over study of two doses of EVT 201 (1.5mg and 2.5mg) in 67 completed patients was conducted in sleep labs in the US using objective polysomnography (PSG). After having published top-line results in a press release on 4 June 2007, the results of the detailed analysis are herewith reported.
The detailed analysis showed that all endpoints achieved an even higher level of statistical significance than first indicated. The pre-specified intention-to-treat analysis of the study showed that on both of the co-primary endpoints of Total Sleep Time (TST) and Wake After Sleep Onset (WASO) the statistical significance of both doses against placebo was p<0.0001.
Highly statistically and clinically meaningful effects were also found on both the Latency to Persistent Sleep (LPS) and TST in the second half of the night, indicating strong effects on both sleep onset and sleep maintenance. In addition to these objective PSG results, there were highly significant improvements, at both dose levels, on the subjective perception of sleep quality.
The following morning there was no subjective perception of any residual sedation. The Digit Symbol Substitution Test (DSST) showed a small but clinically insignificant change tested the next day 9 h after dosing.
The PSG analysis al
|SOURCE Evotec AG|
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