A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Phase of Trial: Phase III
Latest Information Update: 13 Mar 2018
At a glance
- Drugs Lumateperone (Primary)
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Intra-Cellular Therapies
- 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 (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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History