The RESTORA I study is a multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group polysomnography study to confirm the efficacy and safety of almorexant in adult subjects with chronic primary insomnia. The study will enroll approximately 670 patients from over 70 centers in countries from Asia, Australia, Europe, Israel and Latin America. Patients will be randomized 1:1:1:1 to two doses of almorexant (100mg and 200mg), placebo and zolpidem (10mg) as an active reference.
The study is designed to demonstrate the effect of almorexant versus placebo on sleep onset (Latency to Persistent Sleep – LPS) and/or sleep maintenance (Wake-after-sleep onset – WASO) as determined by polysomnography. Secondary objectives of the study include evaluation of almorexant versus placebo on subjective parameters – self reported time to fall asleep (sLPS) and self reported wake time during sleep (sWASO) – as well as safety and tolerability. The study will also provide information about the potential benefits of almorexant on sleep architecture and the potential of this novel agent to restore normal physiological sleep.
RESTORA I also includes an active reference arm with zolpidem to generate reference information with this agent approved for the treatment of insomnia. In order to maximize the full transformational potential of almorexant, Actelion has recently initiated a partnering process to evaluate major pharmaceutical companies in order to select the optimal commercial partner.
Goran Hajak, professor of Psychiatry at the University of Regensburg (Germany) and member of the RESTORA Steering Committee, said: “The RESTORA program, expected to enroll several thousand patients over the coming two to three years will provide us with detailed safety and efficacy information on the potential use of almorexant as an insomnia treatment.”