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
- Completed
- 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
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult
- Age Range
- Adult
- Trial Duration
- January 24, 2023 - January 27, 2025
- Phase
- Phase 3
