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
ClinicalTrials.gov processed this data on November 20, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified November 2024 by Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.Information Provided by (Responsible Party)
Teva Branded Pharmaceutical Products R&D, Inc.Clinicaltrials.gov Identifier
NCT05693935Other Study ID Numbers: TV44749-CNS-30096
First Submitted: January 12, 2023
First Posted: January 23, 2023
Last Update Posted: November 21, 2024
Last Verified: November 2024
History of Changes
Disclaimer
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Participants with exacerbation of schizophrenia may be included. The study will be composed of 2 periods: Period 1 (the double-blind, placebo-controlled, efficacy and safety period) and Period 2 (open-label long term safety period). For each participant, the duration of Period 1 will be 8 weeks, and the duration of Period 2 will be up to 48 weeks. In Period 1, participants will be randomized to one of 3 TV-44749 treatment groups or a placebo group in a 1:1:1:1 ratio. All participants will be randomized again to one of the TV44749 treatment groups in a 1:1:1 ratio for Period 2. The end-of-treatment and follow-up visits will be at 4 and 8 weeks after the last dose of investigational medicinal product administration, respectively.| Condition or Disease | Intervention/Treatment |
|---|---|
|
|
Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 675 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | January 24, 2023 |
| Actual Primary Completion Date | March 19, 2024 |
| Anticipated Study Completion Date | January 13, 2025 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
|---|---|
|
|
|
|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score [Baseline, Week 8] Data gathered from this assessment procedure are applied to the PANSS ratings. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme.
Secondary Outcome Measures
- Change in Clinical Global Impression-Severity (CGI-S) scale score from baseline to week 8 [Baseline, Week 8] The CGI-S rates this severity of a 1-7 scale, with (1) representing normal symptoms, meaning the participant is not ill. The highest on the scale, (7), represents participants among the most severely ill. Right in the middle at (4), a participant will be defined as moderately ill.
- Change in Personal and Social Performance Scale (PSP) score from baseline to week 8 [Baseline, Week 8] The PSP is a clinician-based rating instrument providing an overall rating of personal and social functioning in psychiatric participants on a scale of 0 (grossly impaired functioning) to 100 (excellent functioning).
- Number of participants reporting at least one Adverse Event [Baseline to Week 8] Adverse events (including serious adverse events, extrapyramidal symptoms, injection pain and other injection site reactions), vital signs (blood pressure, pulse and orthostatic changes, and temperature), body weight, lab tests and ECGs.
- Number of participants reporting at least one Adverse Event [Week 8 to Week 60] Adverse events (including serious adverse events, extrapyramidal symptoms, injection pain and other injection site reactions), vital signs (blood pressure, pulse and orthostatic changes, and temperature), body weight, lab tests and ECGs.
- Change in total PANSS score from baseline to weeks 1, 2, and 4 [Baseline, Week 1, Week 2, Week 4]
- Change in Clinical Global Impression-Improvement (CGI-I) scale score from baseline to weeks 4 and 8 [Baseline, Week 4, Week 8] CGI-I scores range from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
- Change in CGI-S scale score from baseline to weeks 1, 2, and 4 [Baseline, Week 1, Week 2, Week 4]
- Change in Patient Global Impression-Improvement (PGI-I) scale score from baseline to week 8 [Baseline, Week 8] The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The lower the score, the better the improvement.
- Change in PGI-I scale score from baseline to weeks 2 and 4 [Baseline, Week 2, Week 4]
- Change in Schizophrenia Quality of Life Scale (SQLS) score from baseline to weeks 4 and 8 [Baseline, Week 4, Week 8] The SQLS questionnaire assesses schizophrenia quality of life. A higher score indicates worse quality of life.
- Change in PSP score from baseline to week 4 [Baseline, Week 4]
- Number of participants reporting use of at least one Concomitant Medication [Baseline to Week 8]
- Number of participants reporting use of at least one Concomitant Medication [Week 8 to Week 60]
- Number of participants that discontinued the trial [Baseline to Week 8]
- Number of participants that discontinued the trial [Week 8 to Week 60]
- Number of participants who Discontinued the trial due to Adverse Events [Baseline to Week 8]
- Number of participants who Discontinued the trial due to Adverse Events [Week 8 to Week 60]
- Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) total score [Baseline to Week 8]
- Change from Baseline in total score in Abnormal Involuntary Movement Scale (AIMS) [Week 8 to Week 60]
- Change from baseline in Simpson-Angus Scale (SAS) mean score [Baseline to Week 8]
- Change from baseline in Simpson-Angus Scale (SAS) mean score [Week 8 to Week 60]
- Change from baseline in Barnes Akathisia Rating Scale (BARS) total score [Baseline to Week 8]
- Change from baseline in Barnes Akathisia Rating Scale (BARS) total score [Week 8 to Week 60]
- Number of participants with any suicidal ideation or suicidal behavior according to the Columbia Suicide Severity Rating Scale (C-SSRS) [Baseline to Week 8]
- Number of participants with any suicidal ideation or suicidal behavior according to the Columbia Suicide Severity Rating Scale (C-SSRS) [Week 8 to Week 60]
- Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS) [Baseline to Week 8]
- Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS) [Week 8 to Week 60]
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 64 Years (Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
|
| Exclusion Criteria |
|
Contacts and Locations
| Sponsors and Collaborators | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Locations |
|
| Investigators |
More Information
Additional Relevant MeSH Terms
- Schizophrenia
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders