Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aripiprazole Lauroxil · 3 trials · 2 indications
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.
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Maximum plasma concentration
Time to maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Regular injections |
| Treatment Group 2 | ACTIVE_COMPARATOR | Regular injections |
| Location | OTHER | Deltoid or Gluteal Muscle |
| Aripiprazole Lauroxil - A | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence A |
| Aripiprazole Lauroxil - B | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence B |
| Aripiprazole Lauroxil - C | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence C |
| Aripiprazole Lauroxil - D | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence D |
| 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...