Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03345979 | A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia | PHASE3 | COMPLETED | 200 | — | — | Nov 15, 2017 | Mar 12, 2019 | Aug 11, 2020 | 16 | United States |
Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Regular injections |
| Treatment Group 2 | ACTIVE_COMPARATOR | Regular injections |
| Name | Type | Description |
|---|---|---|
| Aripiprazole Lauroxil | COMBINATION_PRODUCT | Intramuscular injection; study drug provided using a pre-filled syringe |
| Paliperidone Palmitate | DRUG | Intramuscular injection |
Inclusion Criteria: * Has a diagnosis of schizophrenia * Requires acute treatment for symptoms of schizophrenia * Willing and able to be confined to an inpatient study unit for up to 3-4 weeks * Has experienced at least one previous hospitalization for schizophrenia * Has been able to achieve outpa...