A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Lumateperone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies
  • Most Recent Events

    • 01 May 2017 According to an Intra-Cellular Therapies media release, company has requested guidance from the FDA on the acceptability of Study ITI-007-005 (see profile 211600) and Study ITI-007-301 with supportive evidence from Study ITI-007-302 (see profile 251131), as the basis for the submission of a new drug application (NDA) for the treatment of schizophrenia. The company has provided information and data analyses to the FDA relating to the three studies.
    • 31 Oct 2016 Results of ITI-007-005, ITI-007-301 and ITI-007-302 trials presented at the CNS Summit 2016 Annual Conference, according to an Intra-Cellular Therapies media release.
    • 31 Oct 2016 Results published in an Intra-Cellular Therapies Media Release
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