Study ID: TV44749-CNS-30096

Study Title

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

Teva Identifier

2022-001865-11

ClinicalTrials.gov Identifier

NCT05693935

Study Status

Not yet recruiting

Trial Condition(s)

Schizophrenia

Interventions

Drug: TEV-48574 | Drug: Placebo

Study Description

The primary objective of this study is to evaluate the efficacy of TV-44749 in adult patients with schizophrenia. A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult patients with schizophrenia. A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult patients 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 patients 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.


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Key Participation Requirements

Gender

Female, Male

Age Range

Adult

Trial Duration

January 6, 2023 - June 22, 2025

Phase

Phase 3

Study Type

Interventional