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Date: 2007-12-20
Phase: III
Anouncement: Launch
Biotech: Actelion (Switzerland)
Product: almorexant (orexin receptor antagonist)
Disease: primary insomnia
Country: Asia, Australia, Europe, Israel and Latin America
Other: Restora-1 is a multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group polysomnography study to evaluate efficacy and safety of almorexant in approximately 670 patients diagnosed with primary insomnia. Enrollment will take place in 70 clinical study centers. Study results should become available in 2009. Another phase III study is planned in 2008. It will expand the trial in North America and focus on longer treatment exposure and different populations such as elderly patients.