Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia
NCT07927946, Phase 4, Not yet recruiting, Alejandro Alva
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Higher-Dose Maintenance With ERZOFRI 351 mg in Adults With Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07927946 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Alejandro Alva | ClinicalTrials.gov |
| Conditions | SCHIZOPHRENIA 1 (Disorder) | ClinicalTrials.gov |
| Interventions | Paliperidone Palmitate | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Score | Baseline (Day 1) and Week 12 | Change in clinician-rated CGI-S score from Baseline (Day 1) to Week 12. The CGI-S is a 7-point scale assessing overall severity of mental illness, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Negative changes from baseline indicate improvement. | ClinicalTrials.gov |
| Secondary | Patient Clinical Global Impression-Improvement (PCGI-I) Response | Weeks 4, 8, and 12 | Proportion of participants reporting a PCGI-I score ≤2 ("much improved" or "very much improved"). The PCGI-I is a 7-point patient-reported measure of perceived global improvement, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline, Week 4, Week 8, and Week 12 | Change from baseline in total SAS score. The SAS is a 10-item clinician-rated scale assessing parkinsonian signs. Each item is scored from 0 (normal) to 4 (extreme), with total scores ranging from 0 to 40; higher scores indicate greater severity of parkinsonian symptoms. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Items 1-7 Total Score | Baseline, Week 4, Week 8, and Week 12 | Change from baseline in the total score for AIMS Items 1-7. The AIMS is a clinician-rated scale assessing involuntary movements involving the facial/oral regions, extremities, and trunk. Items 1-7 are each scored from 0 (none) to 4 (severe), with higher scores indicating greater severity of involuntary movements. The total score for Items 1-7 ranges from 0 to 28. | ClinicalTrials.gov |
| Secondary | Correlation Between Serum Prolactin Concentration and Arizona Sexual Experience Scale (ASEX) Total Score | Week 12 | Correlation between serum prolactin concentration (ng/mL) and sexual dysfunction assessed using the Arizona Sexual Experience Scale (ASEX) at Week 12. The ASEX is a five-item questionnaire with total scores ranging from 5 to 30; higher scores indicate greater sexual dysfunction. The relationship will be evaluated using Pearson or Spearman correlation coefficients, as appropriate. | ClinicalTrials.gov |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Response | Weeks 4, 8, and 12 | Proportion of participants achieving a CGI-I score ≤2 ("much improved" or "very much improved"). The CGI-I is a 7-point clinician-rated scale assessing overall clinical improvement relative to baseline, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Arizona Sexual Experience Scale (ASEX) Total Score | Baseline, Weeks 4, 8, and 12 | Change from baseline in ASEX total score at Weeks 4, 8, and 12. The ASEX is a five-item questionnaire assessing sexual functioning, with total scores ranging from 5 to 30. Higher scores indicate greater sexual dysfunction. | ClinicalTrials.gov |
| Other | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 through Week 12 | Number and proportion of participants experiencing treatment-emergent adverse events during the study, with adverse event severity summarized. | ClinicalTrials.gov |
| Other | Change From Screening to Week 12 in Serum Prolactin Concentration | Screening and Week 12 | Change in serum prolactin concentration (ng/mL) from Screening to Week 12 during treatment with ERZOFRI 351 mg Q4W. | ClinicalTrials.gov |
| Other | Mean Change From Baseline in Fasting Glucose | Baseline and Week 12 | Change from baseline to Week 12 in fasting blood glucose concentration, measured in mg/dL. | ClinicalTrials.gov |
| Other | Injection-Site Pain Severity Score | Day 1, Weeks 4 and 8 | Severity of injection-site pain following ERZOFRI administration, assessed by the investigator using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate greater severity. | ClinicalTrials.gov |
| Other | Mean Change From Baseline in QTcF Interval | Baseline, Weeks 4, 8, and 12 | Change from baseline in the QT interval corrected using Fridericia's formula (QTcF), measured in milliseconds (ms), as assessed by 12-lead electrocardiogram (ECG). | ClinicalTrials.gov |
| Other | All-Cause Study Discontinuation | Day 1 through Week 12 | Number and proportion of participants who discontinue the study before Week 12, with reasons for discontinuation summarized. | ClinicalTrials.gov |
| Other | Symptom Breakthrough Before the 4-Week Injection Interval | Day 1 through Week 12 | Proportion of participants experiencing symptom breakthrough before the scheduled 4-week injection interval during the study period, compared with their documented pre-enrollment rate of symptom breakthrough. | ClinicalTrials.gov |
| Other | Number of Unscheduled Clinic Visits for Psychiatric Symptoms | Day 1 through Week 12 | Total number of unscheduled clinic visits related to psychiatric symptoms occurring during the 12-week study period. | ClinicalTrials.gov |
| Other | Mean Change From Baseline in Body Weight | Baseline and Week 12 | Change from baseline to Week 12 in body weight, measured in kilograms (kg). | ClinicalTrials.gov |
| Other | Mean Change From Baseline in Body Mass Index (BMI) | Baseline and Week 12 | Change from baseline to Week 12 in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²). | ClinicalTrials.gov |
| Other | Mean Change From Baseline in Waist Circumference | Baseline and Week 12 | Change from baseline to Week 12 in waist circumference, measured in centimeters (cm). | ClinicalTrials.gov |
| Other | Mean Change From Baseline in Total Cholesterol | Baseline and Week 12 | Change from baseline to Week 12 in serum total cholesterol concentration, measured in mg/dL. | ClinicalTrials.gov |
| Other | Mean Change From Baseline in HDL Cholesterol | Baseline and Week 12 | Change from baseline to Week 12 in high-density lipoprotein (HDL) cholesterol concentration, measured in mg/dL. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)