At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy, Safety, and Tolerability of Olanzapine for Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use as Treatment of Adult Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating TV-44749 and Placebo for Schizophrenia. Completed, enrolled 675 participants across 82 sites in 5 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult participants with schizophrenia Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult participants with schizophrenia. Total study duration is up to 61 weeks, and treatment duration is up to 56 weeks, with weekly visits during the first 8 weeks and then monthly in-clinic visits with weekly calls during the remainder of the treatment period.
Study Details
Timeline
Interventions
In Period 1, 2 monthly injections. In Period 2, up to 12 monthly injections
In Period 1, 2 monthly injections (Period 1 only)