Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03345979
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the efficacy of initiating treatment of schizophrenia with an investigational product followed by a 2-month dose of AL.

Condition or disease Intervention/treatment Phase
Schizophrenia Combination Product: Aripiprazole Lauroxil Drug: Paliperidone Palmitate Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Treatment Group 1
Regular injections
Combination Product: Aripiprazole Lauroxil
Intramuscular injection; study drug provided using a pre-filled syringe
Other Name: ARISTADA

Active Comparator: Treatment Group 2
Regular injections
Drug: Paliperidone Palmitate
Intramuscular injection
Other Name: Invega Sustenna




Primary Outcome Measures :
  1. Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 4 weeks ]
    Change within treatment groups


Secondary Outcome Measures :
  1. Change in PANSS total score [ Time Frame: 4 weeks ]
    Change between treatment groups

  2. Change in PANSS total score [ Time Frame: 9 weeks ]
    Change within treatment groups

  3. Change in PANSS total score [ Time Frame: 25 weeks ]
    Change within treatment groups

  4. Change in PANSS total score [ Time Frame: 9 weeks ]
    Change between treatment groups

  5. Change in PANSS total score [ Time Frame: 25 weeks ]
    Change between treatment groups

  6. Frequency of serious and non-serious adverse events (AEs) [ Time Frame: Up to 25 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345979


Locations
Layout table for location information
United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
Alkermes Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Alkermes Investigational Site
Cerritos, California, United States, 90703
Alkermes Investigational Site
Culver City, California, United States, 90230
Alkermes Investigational Site
Garden Grove, California, United States, 92845
Alkermes Investigational Site
Lemon Grove, California, United States, 91945
United States, Florida
Alkermes Investigational Site
Hialeah, Florida, United States, 33012
United States, Illinois
Alkermes Investigational Site
Chicago, Illinois, United States, 60640
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Mississippi
Alkermes Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nevada
Alkermes Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Alkermes Investigational Site
Berlin, New Jersey, United States, 08009
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States, 78754
Alkermes Investigational Site
Garland, Texas, United States, 75042
Alkermes Investigational Site
Richardson, Texas, United States, 75080
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Layout table for investigator information
Study Director: Sanjeev Pathak, MD Alkermes, Inc.

Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT03345979     History of Changes
Other Study ID Numbers: ALK9072-A306
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Alkermes, Inc.:
Alkermes
schizophrenia
aripiprazole lauroxil
ARISTADA

Additional relevant MeSH terms:
Layout table for MeSH terms
Paliperidone Palmitate
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Aripiprazole lauroxil
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists