drugset / Trial / NCT01895452
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Timeline
- Start
- 2013-07
- Primary completion
- 2016-06
- Completion
- 2016-06
Publications
- McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.
- Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole Lauroxil | Small molecule | 441 mg | Intramuscular |
| Subject | Aripiprazole Lauroxil | Small molecule | 882 mg | Intramuscular |