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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01895452 | An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) | PHASE3 | COMPLETED | 291 | — | — | Jul 1, 2013 | Jun 1, 2016 | Aug 25, 2017 | 57 | United States, Bulgaria +6 |
| NCT01626456 | A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) | PHASE3 | COMPLETED | 478 | — | — | Jun 1, 2012 | Apr 1, 2015 | Sep 25, 2018 | 82 | United States, Bulgaria +6 |
| NCT01469039 | A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia | PHASE3 | COMPLETED | 623 | — | — | Dec 1, 2011 | Mar 1, 2014 | Jan 30, 2019 | 84 | United States, Bulgaria +6 |
| NCT01493726 | A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia | PHASE1 | COMPLETED | 88 | — | — | Dec 1, 2011 | Jun 1, 2013 | Aug 29, 2018 | 6 | United States |
This measure includes all incidences, including those that occurred \>5%.
This measure includes incidences \>5%.
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 |
|---|---|---|
| ALKS 9072, Low Dose | EXPERIMENTAL | - |
| ALKS 9072, High Dose | EXPERIMENTAL | - |
| ALKS 9072, Low | EXPERIMENTAL | - |
| ALKS 9072, High | EXPERIMENTAL | - |
| ALKS 9072 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ALKS 9072, Med dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 9072, Low Dose | DRUG | Intramuscular injection, given monthly |
| ALKS 9072, High Dose | DRUG | Intramuscular injection, given monthly |
| ALKS 9072, Low | DRUG | IM injection, given monthly |
| ALKS 9072, High | DRUG | IM injection, given monthly |
| ALKS 9072 | DRUG | Intramuscular (IM) injection, 441 mg or 882 mg given monthly |
| Placebo | DRUG | Placebo for IM injection, given monthly |
| ALKS 9072, Med dose | DRUG | IM injection, given monthly |
Inclusion Criteria: * Completed the treatment period of Study ALK9072-003EXT * Continues to require chronic treatment with an antipsychotic medication * Continues to reside in a stable living situation * Continues to have an identified reliable informant Exclusion Criteria: * Abnormal clinical la...