A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT05693935

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

675

Starts

2023-01-24

Expected to finish

2025-01-27

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has a current confirmed diagnosis of schizophrenia according to the DSM-5, for >1 year
• The participant has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization for symptoms of schizophrenia.
• Participants who have received an antipsychotic treatment (other than clozapine) in the past year must have been responsive based on the investigator's judgment (and based on discussions with family members, caregivers, or healthcare professionals, as applicable).
• Body mass index between 18.0 and 40.0 kg/m2, inclusive, at the time of screening
• Women may be included only if they have a negative beta-human chorionic gonadotropin (β-HCG) test at screening and baseline
• Women of childbearing potential must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception prior to the first administration of IMP, and agree to continue the use of this method for the duration of the study, and for 70 days after the last dose of IMP
• The participant is in adequate health as determined by medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry, hematology, coagulation urinalysis, and serology.
• NOTE- Additional criteria apply, please contact the investigator for more information

You may not qualify if…

• The participant has a current clinically significant DSM-5 diagnosis other than schizophrenia (has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment).
• The participant has a known history of the following: (a) borderline personality disorder, antisocial personality disorder, or bipolar disorder; (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's disease, or another form of dementia, or any chronic organic disease of the central nervous system; and (c) intellectual disability of a severity that would impact ability to participate in the study.
• The participant was hospitalized for >14 days (with the exception of social or administrative hospitalization) in the current exacerbation episode prior to screening.
• The participant has a significant risk of violent behavior based on the participant's medical history or investigator's judgment.
• The participant has a significant risk of committing suicide based on the participant's medical history or C-SSRS, and the investigator's judgment.
• The participant is currently using an LAI antipsychotic or is still under the coverage period of the specific LAI at time of screening.
• The participant has taken clozapine or has received electroconvulsive therapy within the last 12 months prior to screening.
• The participant is currently receiving daily oral olanzapine at a dose >20 mg/day.
• The participant has current or a history of known hypersensitivity to olanzapine or any of the excipients of TV-44749 or the oral formulation of olanzapine.
• The participant has had a significant sedation or delirium after antipsychotic treatment according to medical and psychiatric history and as judged by the investigator or suffered from delirium due to a medical condition.
• The participant has a non-fasting glucose level of ≥200 mg/dL at screening
• The participant meets criteria for moderate to severe substance use disorder (based on DSM-5 criteria) within the past 6 months (excluding those related to caffeine or nicotine)
• NOTE- Additional criteria apply, please contact the investigator for more information

Where it is running

• Teva Investigational Site 15465 — Little Rock, Arkansas, United States
• Teva Investigational Site 15453 — Rogers, Arkansas, United States
• Teva Investigational Site 15470 — Anaheim, California, United States
• Teva Investigational Site 15459 — Bellflower, California, United States
• Teva Investigational Site 15490 — Garden Grove, California, United States
• Teva Investigational Site 15474 — La Habra, California, United States
• Teva Investigational Site 15481 — Lemon Grove, California, United States
• Teva Investigational Site 15491 — Long Beach, California, United States
• Teva Investigational Site 15497 — Los Angeles, California, United States
• Teva Investigational Site 15482 — Los Angeles, California, United States
• Teva Investigational Site 15450 — Orange, California, United States
• Teva Investigational Site 15455 — Pico Rivera, California, United States
• Teva Investigational Site 15471 — Riverside, California, United States
• Teva Investigational Site 15444 — San Diego, California, United States
• Teva Investigational Site 15449 — Santee, California, United States
• Teva Investigational Site 15461 — Sherman Oaks, California, United States
• Teva Investigational Site 15483 — Torrance, California, United States
• Teva Investigational Site 15457 — Hialeah, Florida, United States
• Teva Investigational Site 15488 — Hollywood, Florida, United States
• Teva Investigational Site 15498 — Hollywood, Florida, United States
• Teva Investigational Site 15458 — Hollywood, Florida, United States
• Teva Investigational Site 15489 — Homestead, Florida, United States
• Teva Investigational Site 15452 — Miami, Florida, United States
• Teva Investigational Site 15495 — Miami, Florida, United States
• Teva Investigational Site 15460 — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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