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

• ClinicalTrials.gov Identifier: NCT03345979
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Results First Posted: August 11, 2020
• Last Update Posted: August 11, 2020
• Sponsor: Alkermes, Inc.
• Information provided by (Responsible Party): Alkermes, Inc.

Tracking Information

• First Submitted Date: November 14, 2017
• First Posted Date: November 17, 2017
• Results First Submitted Date: June 30, 2020
• Results First Posted Date: August 11, 2020
• Last Update Posted Date: August 11, 2020
• Actual Study Start Date: November 15, 2017
• Actual Primary Completion Date: March 12, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2020)

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 [ Time Frame: Baseline and 4 weeks ]

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.

Original Primary Outcome Measures (submitted: November 15, 2017)

Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 4 weeks ]

Change within treatment groups

Current Secondary Outcome Measures (submitted: July 29, 2020)

• Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 [ Time Frame: Baseline and 4 weeks ]
  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
• Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 [ Time Frame: Baseline and 9 weeks ]
  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.
• Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 [ Time Frame: Baseline and 25 weeks ]
  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
• Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 [ Time Frame: Baseline and 9 weeks ]
  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
• Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 [ Time Frame: Baseline and 25 weeks ]
  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
• Number of Participants With Serious and Non-serious Adverse Events (AEs) [ Time Frame: Up to 25 weeks ]

Original Secondary Outcome Measures (submitted: November 15, 2017)

• Change in PANSS total score [ Time Frame: 4 weeks ]
  Change between treatment groups
• Change in PANSS total score [ Time Frame: 9 weeks ]
  Change within treatment groups
• Change in PANSS total score [ Time Frame: 25 weeks ]
  Change within treatment groups
• Change in PANSS total score [ Time Frame: 9 weeks ]
  Change between treatment groups
• Change in PANSS total score [ Time Frame: 25 weeks ]
  Change between treatment groups
• Frequency of serious and non-serious adverse events (AEs) [ Time Frame: Up to 25 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

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

  • ARISTADA
  • ARISTADA INITIO
• Drug: Paliperidone Palmitate
  Intramuscular injection
  Other Name: Invega Sustenna

Study Arms

• Experimental: Treatment Group 1
  Regular injections
  Intervention: Combination Product: Aripiprazole Lauroxil
• Active Comparator: Treatment Group 2
  Regular injections
  Intervention: Drug: Paliperidone Palmitate

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 8, 2018): 200
• Original Estimated Enrollment (submitted: November 15, 2017): 180
• Actual Study Completion Date: March 12, 2019
• Actual Primary Completion Date: March 12, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03345979
• Other Study ID Numbers: ALK9072-A306
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Alkermes, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Alkermes, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sanjeev Pathak, MD; Alkermes, Inc.

• PRS Account: Alkermes, Inc.
• Verification Date: July 2020