drugset / Trial / NCT03345979
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
Timeline
- Start
- 2017-11-15
- Primary completion
- 2019-03-12
- Completion
- 2019-03-12
Outcome
Met primary endpoint
registry analysis (superiority test); Aripiprazole Lauroxil; p <.001; t-test, 2 sided NCT03345979 ↗
paper For AL, the mean baseline PANSST was 94.1; scores were significantly reduced from baseline at week 4 (-17.4; P < .001) PMID 32433835 ↗
release “The ALPINE study met its pre-specified primary endpoint, demonstrating that both ARISTADA and INVEGA SUSTENNA had statistically significant and clinically meaningful reductions” alkermes.com ↗
Publications
- Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
- Citrome L, Yagoda S, Bidollari I, Wang M. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Psychiatry. 2024 Feb 28;85(1):23m15095. doi: 10.4088/JCP.23m15095.
- Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x.
- Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole Lauroxil | Small molecule | 1064 mg | Intramuscular |
| Comparator | paliperidone palmitate | Unknown | 156 mg | Intramuscular |