A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

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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 II

Latest Information Update: 13 Mar 2018

At a glance

  • Drugs Lumateperone (Primary) ; Risperidone
  • Indications Schizophrenia
  • Focus Therapeutic Use
  • Sponsors Intra-Cellular Therapies

    • Most Recent Events

    • 13 Mar 2018 According to an Intra-Cellular Therapies media release, company had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) and plans to complete its NDA submission by mid-2018.
    • 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 and Study ITI-007-301 (see profile 242900) 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.
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