Trial · NCT05693935
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 |
| SECONDARY | Double-blind Period: Change in PSP Score From Baseline to Week 4 | Baseline, Week 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: Number of Participants Receiving At Least 1 Concomitant Medication | 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 Receiving At Least 1 Concomitant Medication | 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 From Baseline to Week 8 in Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Integrated Study Period: Change From Baseline to Week 60 in AIMS Total Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Double-blind Period: Change From Baseline to Week 8 in Simpson-Angus Scale (SAS) Mean Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Integrated Study Period: Change From Baseline to Week 60 in SAS Mean Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Double-blind Period: Change From Baseline to Week 8 in Barnes Akathisia Rating Scale (BARS) Total Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Integrated Study Period: Change From Baseline to Week 60 in BARS Total Score | Baseline, 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. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Double-blind Period: Number of Participants With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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
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GET https://conductscience.org/api/trials/v1/NCT05693935/outcomes