nd time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at 1 and 3 months. Patients who complete the initial 3-month treatment period may participate in an optional 3-month extension period [3].
06/04/2010 09:08:19
NCT01021813: This 12 month US PIII randomised, double-blind, placebo-controlled trial started in Dec 09. The study will investigate the efficacy, safety and tolerability of MK in patients with primary insomnia. An estimated 750 patients will be enrolled. Primary outcome measures are: the proportion of patients who experience (1) narcolepsy-like events, including cataplexy (2) complex sleep-related behaviour, (3) falls, and (4) suicidal ideation and/or behaviours. The trial is scheduled for completion Nov 11 [2]
03/03/2010 08:18:39
Evidence Based eva luations
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