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A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02634320
Recruitment Status : Completed
First Posted : December 18, 2015
Results First Posted : November 8, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Lauroxil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection
Study Start Date : December 2015
Actual Primary Completion Date : July 11, 2017
Actual Study Completion Date : July 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Aripiprazole Lauroxil
Intramuscular (IM) injection
Drug: Aripiprazole Lauroxil
Monthly IM injection
Other Name: ARISTADA




Primary Outcome Measures :
  1. Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores [ Time Frame: Up to 7 months ]
    The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data.


Secondary Outcome Measures :
  1. Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores [ Time Frame: Up to 7 months ]
    The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).

  2. Number of Participants With Adverse Events [ Time Frame: Up to 7 months ]
  3. Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) [ Time Frame: Up to 7 months ]
    The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).

  4. Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) [ Time Frame: Up to 7 months ]
    Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.

  5. Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) [ Time Frame: Up to 7 months ]
    The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or "A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit.



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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 demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
  • Has a diagnosis of schizophrenia
  • Is clinically stable
  • Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
  • Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
  • Agreed to abide by the contraceptive requirements o the protocol
  • Resides in a stable living situation
  • Additional criteria may apply

Exclusion Criteria:

  • Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  • Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
  • Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
  • Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
  • 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): NCT02634320


Locations
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United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 27711
Alkermes Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Alkermes Investigational Site
Anaheim, California, United States, 92805
Alkermes Investigational Site
Culver City, California, United States, 90230
Alkermes Investigational Site
Garden Grove, California, United States, 92845
Alkermes Investigational Site
National City, California, United States, 91950
Alkermes Investigational Site
Oceanside, California, United States, 92056
Alkermes Investigational Site
Orange, California, United States, 92868
Alkermes Investigational Site
Panorama City, California, United States, 91402
United States, Georgia
Alkermes Investigational Site
Augusta, Georgia, United States, 30901
United States, Illinois
Alkermes Investigational Site
Chicago, Illinois, United States, 60640
United States, Louisiana
Alkermes Investigational Site
Shreveport, Louisiana, United States, 71101
United States, Missouri
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Ohio
Alkermes Investigational Site
Garfield Heights, Ohio, United States, 44125
United States, Rhode Island
Alkermes Investigational Site
Lincoln, Rhode Island, United States, 02865
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75231
Alkermes Investigational Site
Dallas, Texas, United States, 75243
Alkermes Investigational Site
DeSoto, Texas, United States, 75115
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] September 7, 2016
Statistical Analysis Plan  [PDF] July 18, 2017


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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02634320     History of Changes
Other Study ID Numbers: ALK9072-A401
First Posted: December 18, 2015    Key Record Dates
Results First Posted: November 8, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alkermes, Inc.:
Alkermes
ARISTADA
Aripiprazole Lauroxil
Schizophrenia

Additional relevant MeSH terms:
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Aripiprazole
Aripiprazole lauroxil
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
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