A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
1 other identifier
interventional
200
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Nov 2017
Shorter than P25 for phase_3 schizophrenia
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2019
CompletedResults Posted
Study results publicly available
August 11, 2020
CompletedAugust 11, 2020
July 1, 2020
1.3 years
November 14, 2017
June 30, 2020
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
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.
Baseline and 4 weeks
Secondary Outcomes (6)
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Baseline and 9 weeks
Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Baseline and 25 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
Baseline and 9 weeks
Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
Baseline and 25 weeks
- +1 more secondary outcomes
Study Arms (2)
Treatment Group 1
EXPERIMENTALRegular injections
Treatment Group 2
ACTIVE COMPARATORRegular injections
Interventions
Intramuscular injection; study drug provided using a pre-filled syringe
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (16)
Alkermes Investigational Site
Little Rock, Arkansas, 72211, United States
Alkermes Investigational Site
Rogers, Arkansas, 72758, United States
Alkermes Investigational Site
Cerritos, California, 90703, United States
Alkermes Investigational Site
Culver City, California, 90230, United States
Alkermes Investigational Site
Garden Grove, California, 92845, United States
Alkermes Investigational Site
Lemon Grove, California, 91945, United States
Alkermes Investigational Site
Hialeah, Florida, 33012, United States
Alkermes Investigational Site
Chicago, Illinois, 60640, United States
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169, United States
Alkermes Investigational Site
Flowood, Mississippi, 39232, United States
Alkermes Investigational Site
St Louis, Missouri, 63141, United States
Alkermes Investigational Site
Las Vegas, Nevada, 89102, United States
Alkermes Investigational Site
Berlin, New Jersey, 08009, United States
Alkermes Investigational Site
Austin, Texas, 78754, United States
Alkermes Investigational Site
Garland, Texas, 75042, United States
Alkermes Investigational Site
Richardson, Texas, 75080, United States
Related Publications (4)
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.
PMID: 39145678DERIVEDCitrome 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.
PMID: 38416865DERIVEDNasrallah 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.
PMID: 34625041DERIVEDWeiden 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.
PMID: 32433835DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Stroynowski
- Organization
- Alkermes, Inc
Study Officials
- STUDY DIRECTOR
Sanjeev Pathak, MD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 17, 2017
Study Start
November 15, 2017
Primary Completion
March 12, 2019
Study Completion
March 12, 2019
Last Updated
August 11, 2020
Results First Posted
August 11, 2020
Record last verified: 2020-07