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Trial Outcomes & Findings for A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia (NCT NCT02634320)

NCT ID: NCT02634320

Last Updated: 2018-12-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

Up to 7 months

Results posted on

2018-12-04

Participant Flow

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.

All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.

Participant milestones

Participant milestones
Measure
Aripiprazole Lauroxil
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Overall Study
STARTED
51
Overall Study
COMPLETED
35
Overall Study
NOT COMPLETED
16

Reasons for withdrawal

Reasons for withdrawal
Measure
Aripiprazole Lauroxil
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Overall Study
Adverse Event
2
Overall Study
Lost to Follow-up
3
Overall Study
Moved out of area
2
Overall Study
Out of window for study visits
1
Overall Study
Protocol Violation
1
Overall Study
Withdrawal by Subject
5
Overall Study
Lack of Efficacy
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aripiprazole Lauroxil
n=51 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
51 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
40 years
STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
37 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
25 Participants
n=5 Participants
Race (NIH/OMB)
White
22 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
51 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 months

Population: Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.

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.

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=49 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
-0.2 units on a scale
Standard Deviation 0.87

SECONDARY outcome

Timeframe: Up to 7 months

Population: Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.

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).

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=49 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
-2.7 units on a scale
Standard Deviation 9.21

SECONDARY outcome

Timeframe: Up to 7 months

Population: Safety population includes all subjects who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=51 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Number of Participants With Adverse Events
21 Participants

SECONDARY outcome

Timeframe: Up to 7 months

Population: Subjects who had at least one dose of study drug and had a last on-treatment visit.

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).

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=49 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
0.4 units on a scale
Standard Deviation 13.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=51 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Spent at least 1 overnight as an inpatient
3 participants
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Attended an outpatient visit for mental health
17 participants
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Had at least 1 visit to an ER
6 participants
Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
Were arrested, picked up, or transported by police
2 participants

SECONDARY outcome

Timeframe: Up to 7 months

Population: Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information.

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.

Outcome measures

Outcome measures
Measure
Aripiprazole Lauroxil
n=19 Participants
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
-3.2 units on a scale
Standard Deviation 12.94

Adverse Events

Aripiprazole Lauroxil

Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Aripiprazole Lauroxil
n=51 participants at risk
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Psychiatric disorders
Psychotic disorder
3.9%
2/51 • Number of events 2 • Up to 7 months
Psychiatric disorders
Suicidal ideation
3.9%
2/51 • Number of events 2 • Up to 7 months
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
2.0%
1/51 • Number of events 1 • Up to 7 months

Other adverse events

Other adverse events
Measure
Aripiprazole Lauroxil
n=51 participants at risk
Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection
Psychiatric disorders
Anxiety
5.9%
3/51 • Number of events 3 • Up to 7 months

Additional Information

ARISTADA Medical Information

Alkermes, Inc.

Phone: 866-204-7823

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER