Phase 3 Study Update of Tasimelteon for Non-24-Hour Sleep-Wake Disorder
Vanda Pharmaceuticals announced that tasimelteon was shown in the Phase 3 RESET study to reset the body clock and to align it to a constant 24-hour day in patients suffering from Non-24-Hour Sleep-Wake Disorder (Non-24-Hour Disorder). This observation was made in four patients during the initial run-in segment of the study.
RESET is a randomized withdrawal study designed to demonstrate the maintenance effect of 20mg tasimelteon in the treatment of Non-24-Hour Disorder. Twenty totally blind individuals with no light perception and diagnosed as having a body clock period of greater than 24 hours, will be treated with tasimelteon for three months during a run-in phase. Patients who respond to tasimelteon treatment during the run-in phase, as measured by the resetting and alignment of their body clock to the 24-hour day, will then be randomized either to receive placebo or to continue receiving tasimelteon for 2 months. During the post-randomization phase, patients will be re-evaluated. RESET is expected to be completed by the end of 2012.
Tasimelteon is a specific and potent agonist of the human MT1 and MT2 receptors. Compounds that selectively bind to melatonin receptors are thought to be able to regulate the body clock, which may be useful to treat circadian rhythm disorders.
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