A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345979
• Other study ID #: ALK9072-A306
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2017
• Est. completion date: March 12, 2019

Study information

• Verified date: July 2020
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 12, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Combination Product:
• Aripiprazole Lauroxil
Intramuscular injection; study drug provided using a pre-filled syringe

Drug:
• Paliperidone Palmitate
Intramuscular injection

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Austin	Texas
United States	Alkermes Investigational Site	Berlin	New Jersey
United States	Alkermes Investigational Site	Cerritos	California
United States	Alkermes Investigational Site	Chicago	Illinois
United States	Alkermes Investigational Site	Culver City	California
United States	Alkermes Investigational Site	Flowood	Mississippi
United States	Alkermes Investigational Site	Garden Grove	California
United States	Alkermes Investigational Site	Garland	Texas
United States	Alkermes Investigational Site	Hialeah	Florida
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Las Vegas	Nevada
United States	Alkermes Investigational Site	Lemon Grove	California
United States	Alkermes Investigational Site	Little Rock	Arkansas
United States	Alkermes Investigational Site	Richardson	Texas
United States	Alkermes Investigational Site	Rogers	Arkansas
United States	Alkermes Investigational Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). 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	Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9	Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks 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 9 weeks
Secondary	Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25	Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks 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 25 weeks
Secondary	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9	Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).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 9 weeks
Secondary	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25	Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. 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 25 weeks
Secondary	Number of Participants With Serious and Non-serious Adverse Events (AEs)		Up to 25 weeks