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
Public ClinicalTrials.gov record NCT05693935. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05693935
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 675 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 24, 2023 (Actual)
- Primary completion
- Mar 19, 2024 (Actual)
- Completion
- Jan 27, 2025 (Actual)
- Last update posted
- Mar 17, 2026
2023 – 2025
United States locations
- U.S. sites
- 53
- U.S. states
- 14
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 15460 | Bentonville | Arkansas | 72712 | — |
| Teva Investigational Site 15465 | Little Rock | Arkansas | 72211 | — |
| Teva Investigational Site 15453 | Rogers | Arkansas | 72758 | — |
| Teva Investigational Site 15470 | Anaheim | California | 92805 | — |
| Teva Investigational Site 15459 | Bellflower | California | 90706 | — |
| Teva Investigational Site 15490 | Garden Grove | California | 92845 | — |
| Teva Investigational Site 15474 | La Habra | California | 90631 | — |
| Teva Investigational Site 15481 | Lemon Grove | California | 91945 | — |
| Teva Investigational Site 15491 | Long Beach | California | 90807 | — |
| Teva Investigational Site 15497 | Los Angeles | California | 90015 | — |
| Teva Investigational Site 15482 | Los Angeles | California | 91436 | — |
| Teva Investigational Site 15450 | Orange | California | 92868 | — |
| Teva Investigational Site 15455 | Pico Rivera | California | 90660 | — |
| Teva Investigational Site 15471 | Riverside | California | 92506 | — |
| Teva Investigational Site 15444 | San Diego | California | 92123 | — |
| Teva Investigational Site 15449 | Santee | California | 92071 | — |
| Teva Investigational Site 15461 | Sherman Oaks | California | 91403 | — |
| Teva Investigational Site 15483 | Torrance | California | 90504 | — |
| Teva Investigational Site 15457 | Hialeah | Florida | 33016 | — |
| Teva Investigational Site 15488 | Hollywood | Florida | 33021 | — |
| Teva Investigational Site 15498 | Hollywood | Florida | 33021 | — |
| Teva Investigational Site 15458 | Hollywood | Florida | 33024 | — |
| Teva Investigational Site 15489 | Homestead | Florida | 33030 | — |
| Teva Investigational Site 15452 | Miami | Florida | 33122 | — |
| Teva Investigational Site 15495 | Miami | Florida | 33122 | — |
| Teva Investigational Site 15446 | Miami | Florida | 33155 | — |
| Teva Investigational Site 15456 | Miami | Florida | 33155 | — |
| Teva Investigational Site 15479 | Miami | Florida | 33155 | — |
| Teva Investigational Site 15462 | Miami | Florida | 33173 | — |
| Teva Investigational Site 15496 | Miami | Florida | 33176-2302 | — |
| Teva Investigational Site 15494 | Miami Lakes | Florida | 33014 | — |
| Teva Investigational Site 15467 | Miami Lakes | Florida | 33016 | — |
| Teva Investigational Site 15473 | Miami Lakes | Florida | 33016 | — |
| Teva Investigational Site 15484 | Miami Springs | Florida | 33166 | — |
| Teva Investigational Site 15477 | West Palm Beach | Florida | 33407 | — |
| Teva Investigational Site 15468 | Atlanta | Georgia | 30331 | — |
| Teva Investigational Site 15469 | Decatur | Georgia | 30030 | — |
| Teva Investigational Site 15500 | Peachtree Corners | Georgia | 30071 | — |
| Teva Investigational Site 15485 | Chicago | Illinois | 60640 | — |
| Teva Investigational Site 15480 | Chicago | Illinois | 60641 | — |
| Teva Investigational Site 15447 | Shreveport | Louisiana | 71101 | — |
| Teva Investigational Site 15442 | Gaithersburg | Maryland | 20877 | — |
| Teva Investigational Site 15466 | Flowood | Mississippi | 39232 | — |
| Teva Investigational Site 15487 | St Louis | Missouri | 63141 | — |
| Teva Investigational Site 15451 | Marlton | New Jersey | 08053 | — |
| Teva Investigational Site 15441 | Charlotte | North Carolina | 28211 | — |
| Teva Investigational Site 15454 | Dayton | Ohio | 45417 | — |
| Teva Investigational Site 15472 | North Canton | Ohio | 44720 | — |
| Teva Investigational Site 15478 | Oklahoma City | Oklahoma | 73112 | — |
| Teva Investigational Site 15448 | Austin | Texas | 78754 | — |
| Teva Investigational Site 15486 | DeSoto | Texas | 75115 | — |
| Teva Investigational Site 15464 | Irving | Texas | 75062 | — |
| Teva Investigational Site 15443 | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05693935, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05693935 live on ClinicalTrials.gov.