Study to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

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 (SOLARIS)
Teva Identifier
TV44749-CNS-30096
ClinicalTrials.gov Identifier
NCT05693935
Study Status
Active, not recruiting
Trial Condition(s)
Schizophrenia
Interventions
Drug: TV-44749 | Drug: Placebo
EudraCT Number
2022-001865-11

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.

Participation requirements include:
- Having been diagnosed with schizophrenia for at least 1 year
- Experiencing a worsening of your schizophrenia within the last 8 weeks
* Please see complete requirements via inclusion and exclusion criteria link

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EudraCT Link


Key Participation Requirements

Gender
Female, Male
Age Range
Adult
Trial Duration
January 24, 2023 - January 13, 2025
Phase
Phase 3

Study Type

Interventional