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A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia.

Trial Profile

A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Jul 2012

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Sleep maintenance insomnia
  • Focus Therapeutic Use
  • Sponsors Intra-Cellular Therapies
  • Most Recent Events

    • 10 Mar 2009 Secondary endpoints 'Sleep efficiency' 'Total sleep time' has been met, according to an Intra-Cellular Therapeutics media release.
    • 10 Mar 2009 Final results have been reported in an Intra Cellular Therapies media release.
    • 13 Jan 2009 Primary endpoints 'Polysomnographic measures' and 'Wake time after sleep onset' have been met, according to an Intra-Cellular therapies media release.
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