Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole Lauroxil
Enrollment 51
Recruitment Details Subjects had schizophrenia, and had been taking paliperidone palmitate (PP) or Risperidone long-acting injection (RLAI) with inadequate results for at least 3 doses prior to screening.
Pre-assignment Details All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Period Title: Overall Study
Started 51
Completed 35
Not Completed 16
Reason Not Completed
Adverse Event             2
Lost to Follow-up             3
Moved out of area             2
Out of window for study visits             1
Protocol Violation             1
Withdrawal by Subject             5
Lack of Efficacy             2
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
The Safety population included all subjects who received at least one dose of study drug. All analyses were performed on the Safety population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
0
   0.0%
Between 18 and 65 years
51
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
40  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
14
  27.5%
Male
37
  72.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
25
  49.0%
White
22
  43.1%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
 100.0%
1.Primary Outcome
Title Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
Hide Description 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.
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Lauroxil
Comments [Not Specified]
Type of Statistical Test Other
Comments Statistical test is to confirm the change from baseline is statistically different from 0.
Statistical Test of Hypothesis P-Value 0.078
Comments Change from baseline at last on-treatment visit
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
Hide Description 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).
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.7  (9.21)
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all subjects who received at least 1 dose of study drug.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
21
  41.2%
4.Secondary Outcome
Title Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
Hide Description 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).
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had at least one dose of study drug and had a last on-treatment visit.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (13.11)
5.Secondary Outcome
Title Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Hide Description 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.
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
Spent at least 1 overnight as an inpatient 3
Attended an outpatient visit for mental health 17
Had at least 1 visit to an ER 6
Were arrested, picked up, or transported by police 2
6.Secondary Outcome
Title Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
Hide Description 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.
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information.
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description:

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (12.94)
Time Frame Up to 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Lauroxil
Hide Arm/Group Description

Intramuscular (IM) injection

Aripiprazole Lauroxil: Monthly IM injection

All-Cause Mortality
Aripiprazole Lauroxil
Affected / at Risk (%)
Total   0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Lauroxil
Affected / at Risk (%) # Events
Total   5/51 (9.80%)    
Psychiatric disorders   
Psychotic disorder * 1  2/51 (3.92%)  2
Suicidal ideation * 2  2/51 (3.92%)  2
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 2  1/51 (1.96%)  1
1
Term from vocabulary, MedDRA V19
2
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Lauroxil
Affected / at Risk (%) # Events
Total   3/51 (5.88%)    
Psychiatric disorders   
Anxiety * 1  3/51 (5.88%)  3
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
Results Point of Contact
Name/Title: ARISTADA Medical Information
Organization: Alkermes, Inc.
Phone: 866-204-7823
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02634320     History of Changes
Other Study ID Numbers: ALK9072-A401
First Submitted: December 16, 2015
First Posted: December 18, 2015
Results First Submitted: July 11, 2018
Results First Posted: November 8, 2018
Last Update Posted: December 4, 2018