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
Results First Posted : August 11, 2020
Last Update Posted : August 11, 2020
|
Sponsor:
Alkermes, Inc.
Information provided by (Responsible Party):
Alkermes, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Schizophrenia |
| Interventions |
Combination Product: Aripiprazole Lauroxil Drug: Paliperidone Palmitate |
| Enrollment | 200 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Of the 200 patients enrolled and randomized to treatment, there were 195 patients included in the full analysis set. These were patients who randomized, received 1 dose study drug and had at least one post-baseline Positive and Negative Syndrome Scale (PANSS) assessment. |
| Arm/Group Title | Aripiprazole Lauroxil | Paliperidone Palmitate |
|---|---|---|
 Arm/Group Description |
Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter | Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter |
| Period Title: Overall Study | ||
| Started | 99 | 101 |
| Completed | 56 | 43 |
| Not Completed | 43 | 58 |
| Reason Not Completed | ||
| Withdrawal by Subject | 20 | 31 |
| Adverse Event | 10 | 11 |
| Lost to Follow-up | 8 | 9 |
| Lack of Efficacy | 4 | 2 |
| Protocol Violation | 1 | 3 |
| Physician Decision | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Aripiprazole Lauroxil | Paliperidone Palmitate | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter | Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter | Total of all reporting groups | |
| Overall Number of Baseline Participants | 99 | 101 | 200 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 99 participants | 101 participants | 200 participants | |
| 43.5 (9.67) | 43.4 (10.83) | 43.4 (10.25) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 99 participants | 101 participants | 200 participants | |
| Female |
26 26.3%
|
25 24.8%
|
51 25.5%
|
|
| Male |
73 73.7%
|
76 75.2%
|
149 74.5%
|
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 99 participants | 101 participants | 200 participants | |
| Hispanic or Latino |
8 8.1%
|
11 10.9%
|
19 9.5%
|
|
| Not Hispanic or Latino |
91 91.9%
|
90 89.1%
|
181 90.5%
|
|
| Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 99 participants | 101 participants | 200 participants | |
| American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Asian |
2 2.0%
|
4 4.0%
|
6 3.0%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Black or African American |
72 72.7%
|
78 77.2%
|
150 75.0%
|
|
| White |
25 25.3%
|
17 16.8%
|
42 21.0%
|
|
| More than one race |
0 0.0%
|
2 2.0%
|
2 1.0%
|
|
| Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
||||
| Number Analyzed | 96 participants | 99 participants | 195 participants | |
| 94.1 (9.04) | 94.6 (8.41) | 94.4 (8.71) | ||
|
[1]
Measure Description: The Positive and Negative Syndrome Scale (PANSS) 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.
[2]
Measure Analysis Population Description: FAS population includes those who were randomized and received at least one dose of study drug and have at least one post-baseline Positive and Negative Syndrome Scale (PANSS) assessment
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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: | Eva Stroynowski |
| Organization: | Alkermes, Inc |
| Phone: | 7816097000 |
| EMail: | eva.stroynowski@alkermes.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT03345979 |
| Other Study ID Numbers: |
ALK9072-A306 |
| First Submitted: | November 14, 2017 |
| First Posted: | November 17, 2017 |
| Results First Submitted: | June 30, 2020 |
| Results First Posted: | August 11, 2020 |
| Last Update Posted: | August 11, 2020 |