Trial · NCT05693935
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
NCT05693935, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D LLC; results first posted 2026-01-09
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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. Trials, record NCT05693935. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05693935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05693935
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 675 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Schizophrenia
- Interventions
- TV-44749, Placebo
- First posted
- 2023-01-23
- Last updated
- 2026-03-17
- Other registries' IDs
- eudract:2022-001865-11
- Results first posted
- 2026-01-09
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Baseline, Week 8 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. |
| Secondary | Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Baseline, Week 8 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. |
| Secondary | Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | Baseline, Week 8 | The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, where 0 (grossly impaired functioning) to 100 (excellent functioning). The score was based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors. Higher scores represented better personal and social functioning, with ratings from 91 to 100 indicating more than adequate functioning, while scores under 30 indicating poor functioning that required intensive supervision. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PSP score at baseline as covariates. |
| Secondary | Double-blind Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 8 | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. |
| Secondary | Integrated Study Period: Number of Participants With AEs and SAEs | Baseline up to Week 60 | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. |
| Secondary | Double-blind Period: Change in PANSS Total Score From Baseline to Weeks 1, 2, and 4 | Baseline, Weeks 1, 2, and 4 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. |
| Secondary | Double-blind Period: Clinical Global Impression-Improvement (CGI-I) Scale Score at Weeks 4 and 8 | Weeks 4 and 8 | The CGI-I is a 7-point scale that permits a global evaluation of the participant's overall improvement in symptoms on a scale of 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-I score at baseline as covariates. |
| Secondary | Double-blind Period: Change in CGI-S Scale Score From Baseline to Weeks 1, 2, and 4 | Baseline, Weeks 1, 2, and 4 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. |
| Secondary | Double-blind Period: Patient Global Impression-Improvement (PGI-I) Scale Score at Weeks 2, 4, and 8 | Weeks 2, 4, and 8 | The PGI-I scale is a 1-item participant-rated instrument that measures improvement of the participant's disease. The participant rated the perceived change in his/her condition in response to therapy on a scale of 1 to 7, where 1=very much better, 2=much better, 3=a little better, 4=no change, 5=a little worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PGI-I score at baseline as covariates. |
| Secondary | Double-blind Period: Change in Schizophrenia Quality of Life Scale (SQLS) Total Score From Baseline to Weeks 4 and 8 | Baseline, Weeks 4 and 8 | The SQLS Revision 4 was administered to capture quality of life. The 33-item measure yields subscales pertaining to psychosocial (20 items) and cognition/vitality factors (13 items). Each item was scored on a 5-point scale (1 - never, 2 - rarely, 3 - sometimes, 4 - often, 5 - always). Individual domain and total scores were standardized by scoring algorithm from 0 (best health status) to 100 (worst health status) scale, with higher scores indicating comparatively lower quality of life. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Baseline, Week 8 | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Baseline, Week 8 | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | Baseline, Week 8 | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 8 | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Integrated Study Period: Number of Participants With AEs and SAEs | Baseline up to Week 60 | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Double-blind Period: Change in PANSS Total Score From Baseline to Weeks 1, 2, and 4 | Baseline, Weeks 1, 2, and 4 | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Clinical Global Impression-Improvement (CGI-I) Scale Score at Weeks 4 and 8 | Weeks 4 and 8 | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Change in CGI-S Scale Score From Baseline to Weeks 1, 2, and 4 | Baseline, Weeks 1, 2, and 4 | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Patient Global Impression-Improvement (PGI-I) Scale Score at Weeks 2, 4, and 8 | Weeks 2, 4, and 8 | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind Period: Change in Schizophrenia Quality of Life Scale (SQLS) Total Score From Baseline to Weeks 4 and 8 | Baseline, Weeks 4 and 8 | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Double-blind: Placebo | -12.17 | 95% Confidence Interval -15.34 to -8.99 | units on a scale | |
| Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Double-blind: TV-44749 318 mg | -21.91 | 95% Confidence Interval -25.13 to -18.70 | units on a scale | |
| Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Double-blind: TV-44749 425 mg | -23.44 | 95% Confidence Interval -26.52 to -20.36 | units on a scale | |
| Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | Double-blind: TV-44749 531 mg | -21.93 | 95% Confidence Interval -25.01 to -18.85 | units on a scale | |
| Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Double-blind: Placebo | -0.72 | 95% Confidence Interval -0.90 to -0.54 | units on a scale | |
| Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Double-blind: TV-44749 318 mg | -1.25 | 95% Confidence Interval -1.43 to -1.07 | units on a scale | |
| Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Double-blind: TV-44749 425 mg | -1.33 | 95% Confidence Interval -1.51 to -1.15 | units on a scale | |
| Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | Double-blind: TV-44749 531 mg | -1.19 | 95% Confidence Interval -1.36 to -1.01 | units on a scale | |
| Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | Double-blind: Placebo | 5.59 | 95% Confidence Interval 3.14 to 8.04 | units on a scale | |
| Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | Double-blind: TV-44749 318 mg | 10.31 | 95% Confidence Interval 7.91 to 12.72 | units on a scale |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period (8 Weeks) | STARTED | Placebo | 168 | |
| Double-blind Period (8 Weeks) | STARTED | TV-44749 318 mg | 169 | |
| Double-blind Period (8 Weeks) | STARTED | TV-44749 425 mg | 169 | |
| Double-blind Period (8 Weeks) | STARTED | TV-44749 531 mg | 169 | |
| Double-blind Period (8 Weeks) | STARTED | Placebo to TV-44749 318 mg | 0 | |
| Double-blind Period (8 Weeks) | STARTED | Placebo to TV-44749 425 mg | 0 | |
| Double-blind Period (8 Weeks) | STARTED | Placebo to TV-44749 531 mg | 0 | |
| Double-blind Period (8 Weeks) | Received at Least 1 Dose of Study Drug | Placebo | 167 | |
| Double-blind Period (8 Weeks) | Received at Least 1 Dose of Study Drug | TV-44749 318 mg | 164 | |
| Double-blind Period (8 Weeks) | Received at Least 1 Dose of Study Drug | TV-44749 425 mg | 168 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events287
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Double Blind Period: Placebo | 6 | 167 | 6 |
| other | Constipation | Gastrointestinal disorders | Double Blind Period: TV-44749 318 mg | 4 | 163 | 4 |
| other | Constipation | Gastrointestinal disorders | Double Blind Period: TV-44749 425 mg | 8 | 168 | 8 |
| other | Constipation | Gastrointestinal disorders | Double Blind Period: TV-44749 531 mg | 8 | 169 | 10 |
| other | Constipation | Gastrointestinal disorders | Integrated Study Period: TV-44749 318 mg | 7 | 204 | 7 |
| other | Constipation | Gastrointestinal disorders | Integrated Study Period: TV-44749 425 mg | 12 | 203 | 12 |
| other | Constipation | Gastrointestinal disorders | Integrated Study Period: TV-44749 531 mg | 9 | 197 | 11 |
| other | Injection site erythema | General disorders | Double Blind Period: Placebo | 1 | 167 | 1 |
| other | Injection site erythema | General disorders | Double Blind Period: TV-44749 318 mg | 12 | 163 | 14 |
| other | Injection site erythema | General disorders | Double Blind Period: TV-44749 425 mg | 21 | 168 | 25 |
1 to 10 of 287Source ClinicalTrials.gov
See all 287 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind Period: Placebo | 0 | 168 |
| Total, all-cause mortality | Double Blind Period: TV-44749 318 mg | 0 | 169 |
| Total, all-cause mortality | Double Blind Period: TV-44749 425 mg | 0 | 169 |
| Total, all-cause mortality | Double Blind Period: TV-44749 531 mg | 0 | 169 |
| Total, all-cause mortality | Integrated Study Period: TV-44749 318 mg | 2 | 209 |
| Total, all-cause mortality | Integrated Study Period: TV-44749 425 mg | 0 | 204 |
| Total, all-cause mortality | Integrated Study Period: TV-44749 531 mg | 1 | 198 |
| Total, other adverse events | Double Blind Period: Placebo | 38 | 167 |
| Total, other adverse events | Double Blind Period: TV-44749 318 mg | 82 | 163 |
| Total, other adverse events | Double Blind Period: TV-44749 425 mg | 99 | 168 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05693935
GET https://conductscience.org/api/trials/v1/NCT05693935/registered?page=2