Phase 3
Completed N=200
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Source: ClinicalTrials.gov NCT03345979 ↗Enrolled (actual)
200
Serious AEs
7.5%
Results posted
Aug 2020
Primary outcomePrimary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 — -17.4; -20.1 units on a scale — p=<.001
◆ Published Evidence
Established
20citations · ~3 / year
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.
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.
Linked Publications (4)
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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.
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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.
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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.
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Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 |
-17.4; -20.1 | <.001 sig |
| SECONDARY Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 |
-17.3; -19.3 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 |
-19.8; -22.5 | — |
| SECONDARY Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 |
-23.3; -21.7 | — |
| SECONDARY Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 |
-18.8; -21.5 | — |
| SECONDARY Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 |
-22.0; -21.1 | — |
| SECONDARY Number of Participants With Serious and Non-serious Adverse Events (AEs) |
69; 72 | — |
Eligibility Criteria
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 outpatient status for more than 3 months in the past year
- Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2
- Resides in a stable living situation when not hospitalized
- Has an identified reliable caregiver (for example, family member)
- Additional criteria may apply
Exclusion Criteria
- Poses a current suicide risk
- Pregnant, planning to become pregnant, or breastfeeding
- Initiated first antipsychotic treatment within the past 12 months
- Has received a long-acting injectable antipsychotic in the past 3 months
- Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product.
- A positive urine drug test for drugs of abuse
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT03345979) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.