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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05693935
Other study ID # TV44749-CNS-30096
Secondary ID 2022-001865-11
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 24, 2023
Est. completion date January 13, 2025

Study information

Verified date April 2024
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 675
Est. completion date January 13, 2025
Est. primary completion date March 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - 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 (ß-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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TV-44749 - Dose level 1
In Period 1, 2 monthly injections. In Period 2, up to 12 monthly injections
TV-44749 - Dose level 2
In Period 1, 2 monthly injections, In Period 2 up to 12 monthly injections
TV-44749 - Dose level 3
In Period 1, 2 monthly injections. In Period 2, up to 12 monthly injections
Placebo
In Period 1, 2 monthly injections (Period 1 only)

Locations

Country Name City State
Bulgaria Teva Investigational Site 59210 Bourgas
Bulgaria Teva Investigational Site 59203 Kazanlak
Bulgaria Teva Investigational Site 59208 Lovech
Bulgaria Teva Investigational Site 59214 Pleven
Bulgaria Teva Investigational Site 59207 Plovdiv
Bulgaria Teva Investigational Site 59215 Razgrad
Bulgaria Teva Investigational Site 59202 Rousse
Bulgaria Teva Investigational Site 59211 Sliven
Bulgaria Teva Investigational Site 59205 Sofia
Bulgaria Teva Investigational Site 59212 Sofia
Bulgaria Teva Investigational Site 59209 Veliko Tarnovo
Bulgaria Teva Investigational Site 59206 Vratsa
China Teva Investigational Site 88052 Beijing
China Teva Investigational Site 88044 Hangzhou Shi
China Teva Investigational Site 88060 Hefei
China Teva Investigational Site 88055 Jining Shi
China Teva Investigational Site 88068 Nanchang Shi
China Teva Investigational Site 88053 Shanghai
China Teva Investigational Site 88054 Tianjin Shi
China Teva Investigational Site 88071 Wuhan
China Teva Investigational Site 88072 Xinxiang
China Teva Investigational Site 88064 Zhumadian
Romania Teva Investigational Site 52124 Bucuresti
Romania Teva Investigational Site 52127 Bucuresti
Romania Teva Investigational Site 52123 Iasi
Romania Teva Investigational Site 52126 Iasi
Turkey Teva Investigational Site 82058 Adapazari
Turkey Teva Investigational Site 82059 Ankara
Turkey Teva Investigational Site 82057 Bursa
United States Teva Investigational Site 15470 Anaheim California
United States Teva Investigational Site 15468 Atlanta Georgia
United States Teva Investigational Site 15448 Austin Texas
United States Teva Investigational Site 15459 Bellflower California
United States Teva Investigational Site 15460 Bentonville Arkansas
United States Teva Investigational Site 15441 Charlotte North Carolina
United States Teva Investigational Site 15480 Chicago Illinois
United States Teva Investigational Site 15485 Chicago Illinois
United States Teva Investigational Site 15454 Dayton Ohio
United States Teva Investigational Site 15469 Decatur Georgia
United States Teva Investigational Site 15486 DeSoto Texas
United States Teva Investigational Site 15466 Flowood Mississippi
United States Teva Investigational Site 15442 Gaithersburg Maryland
United States Teva Investigational Site 15490 Garden Grove California
United States Teva Investigational Site 15457 Hialeah Florida
United States Teva Investigational Site 15458 Hollywood Florida
United States Teva Investigational Site 15488 Hollywood Florida
United States Teva Investigational Site 15498 Hollywood Florida
United States Teva Investigational Site 15489 Homestead Florida
United States Teva Investigational Site 15464 Irving Texas
United States Teva Investigational Site 15474 La Habra California
United States Teva Investigational Site 15481 Lemon Grove California
United States Teva Investigational Site 15465 Little Rock Arkansas
United States Teva Investigational Site 15491 Long Beach California
United States Teva Investigational Site 15482 Los Angeles California
United States Teva Investigational Site 15497 Los Angeles California
United States Teva Investigational Site 15451 Marlton New Jersey
United States Teva Investigational Site 15446 Miami Florida
United States Teva Investigational Site 15452 Miami Florida
United States Teva Investigational Site 15456 Miami Florida
United States Teva Investigational Site 15462 Miami Florida
United States Teva Investigational Site 15479 Miami Florida
United States Teva Investigational Site 15495 Miami Florida
United States Teva Investigational Site 15496 Miami Florida
United States Teva Investigational Site 15467 Miami Lakes Florida
United States Teva Investigational Site 15473 Miami Lakes Florida
United States Teva Investigational Site 15494 Miami Lakes Florida
United States Teva Investigational Site 15484 Miami Springs Florida
United States Teva Investigational Site 15472 North Canton Ohio
United States Teva Investigational Site 15478 Oklahoma City Oklahoma
United States Teva Investigational Site 15450 Orange California
United States Teva Investigational Site 15500 Peachtree Corners Georgia
United States Teva Investigational Site 15455 Pico Rivera California
United States Teva Investigational Site 15443 Richardson Texas
United States Teva Investigational Site 15471 Riverside California
United States Teva Investigational Site 15453 Rogers Arkansas
United States Teva Investigational Site 15487 Saint Louis Missouri
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 15447 Shreveport Louisiana
United States Teva Investigational Site 15483 Torrance California
United States Teva Investigational Site 15477 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Romania,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to week 8 in the Positive and Negative Syndrome Scale (PANSS) total score 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. Baseline, Week 8
Secondary Change in Clinical Global Impression-Severity (CGI-S) scale score from baseline to 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. Baseline, Week 8
Secondary Change in Personal and Social Performance Scale (PSP) score from baseline to 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). Baseline, Week 8
Secondary Number of participants reporting at least one Adverse Event 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. Baseline to Week 8
Secondary Number of participants reporting at least one Adverse Event 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. Week 8 to Week 60
Secondary Change in total PANSS score from baseline to weeks 1, 2, and 4 Baseline, Week 1, Week 2, Week 4
Secondary Change in Clinical Global Impression-Improvement (CGI-I) scale score from baseline to weeks 4 and 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. Baseline, Week 4, Week 8
Secondary Change in CGI-S scale score from baseline to weeks 1, 2, and 4 Baseline, Week 1, Week 2, Week 4
Secondary Change in Patient Global Impression-Improvement (PGI-I) scale score from baseline to 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. Baseline, Week 8
Secondary Change in PGI-I scale score from baseline to weeks 2 and 4 Baseline, Week 2, Week 4
Secondary Change in Schizophrenia Quality of Life Scale (SQLS) score from baseline to weeks 4 and 8 The SQLS questionnaire assesses schizophrenia quality of life. A higher score indicates worse quality of life. Baseline, Week 4, Week 8
Secondary Change in PSP score from baseline to week 4 Baseline, Week 4
Secondary Number of participants reporting use of at least one Concomitant Medication Baseline to Week 8
Secondary Number of participants reporting use of at least one Concomitant Medication Week 8 to Week 60
Secondary Number of participants that discontinued the trial Baseline to Week 8
Secondary Number of participants that discontinued the trial Week 8 to Week 60
Secondary Number of participants who Discontinued the trial due to Adverse Events Baseline to Week 8
Secondary Number of participants who Discontinued the trial due to Adverse Events Week 8 to Week 60
Secondary Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) total score Baseline to Week 8
Secondary Change from Baseline in total score in Abnormal Involuntary Movement Scale (AIMS) Week 8 to Week 60
Secondary Change from baseline in Simpson-Angus Scale (SAS) mean score Baseline to Week 8
Secondary Change from baseline in Simpson-Angus Scale (SAS) mean score Week 8 to Week 60
Secondary Change from baseline in Barnes Akathisia Rating Scale (BARS) total score Baseline to Week 8
Secondary Change from baseline in Barnes Akathisia Rating Scale (BARS) total score Week 8 to Week 60
Secondary Number of participants with any suicidal ideation or suicidal behavior according to the Columbia Suicide Severity Rating Scale (C-SSRS) Baseline to Week 8
Secondary 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
Secondary Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS) Baseline to Week 8
Secondary Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS) Week 8 to Week 60
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