Trial Outcomes & Findings for A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite® (NCT NCT03892889)
NCT ID: NCT03892889
Last Updated: 2021-09-05
Results Overview
Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.
TERMINATED
PHASE3
277 participants
Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)
2021-09-05
Participant Flow
Participants took part in the study at 58 investigative sites in the United States from 29 April 2019 to 12 August 2020.
Participants who were on oral standard-of-care antipsychotic treatments for a period of 6 months prior to Baseline (Day 1) were assessed retrospectively and were enrolled in the Prospective Period on Day 1 to receive Abilify MyCite® for a period of 3 months (Months 1 to 3) and to continue with same treatment or standard of care up to Month 6.
Participant milestones
| Measure |
Abilify MyCite®
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Overall Study
STARTED
|
277
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
204
|
Reasons for withdrawal
| Measure |
Abilify MyCite®
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
46
|
|
Overall Study
Non-compliance with study drug
|
22
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Deviation
|
3
|
|
Overall Study
Withdrawal by Subject
|
50
|
|
Overall Study
Withdrawal by Caregiver
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
50
|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Reason not Specified
|
5
|
Baseline Characteristics
A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Baseline characteristics by cohort
| Measure |
Abilify MyCite®
n=277 Participants
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Age, Continuous
|
44.2 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
223 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective Period [Month -6 to Baseline (Day 1)] up to Prospective Period (Day 1 to Month 3)Population: Modified Intent-to-Treat (mITT) Sample included data from all participants entering the prospective phase who have completed the first 3-months of dosing on Abilify MyCite®.
Percentage of participants with inpatient psychiatric hospitalization in Prospective Period With at least one hospitalization in Retrospective Period.
Outcome measures
| Measure |
Abilify MyCite®
n=113 Participants
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Percentage of Participants With Inpatient Psychiatric Hospitalization
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Retrospective Period [-1 to -3 months prior to Baseline (Day 1)] up to Prospective Period (1 to 3 months)Population: ITT Sample included all enrolled sample who met the study inclusion/exclusion criteria and who are intended to receive study medication in the Prospective Phase. Overall number analyzed is the number of participants with confirmed retrospective prescription data to conduct the PDC calculation.
Improved adherence was based on the overall proportion of days covered (PDC) in participants compliant with study drug administration in the Prospective period on Prospective Abilify MyCite® versus Retrospective Period on oral atypical antipsychotics. PDC was calculated as = number of days 'covered' in the Respective Period/number of days in the period \* 100.
Outcome measures
| Measure |
Abilify MyCite®
n=162 Participants
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Percentage of Days With Improved Adherence
PDC in Retrospective Period
|
51.0 percentage of days
Standard Deviation 37.9
|
|
Percentage of Days With Improved Adherence
PDC in Prospective Period
|
77.5 percentage of days
Standard Deviation 31.8
|
Adverse Events
Abilify MyCite®
Serious adverse events
| Measure |
Abilify MyCite®
n=277 participants at risk
Participants received Abilify MyCite® a combination product of aripiprazole tablet embedded with sensor and wearable patch for 3 months (Months 1 to 3) and continued for an additional 3 months (Months 4 to 6) as per investigators assessment or switch to a standard-of-care treatment of oral atypical antipsychotics or a long acting injectable.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.36%
1/277 • Up to 6 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.36%
1/277 • Up to 6 months
|
|
Infections and infestations
Pneumonia Bacterial
|
0.36%
1/277 • Up to 6 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.36%
1/277 • Up to 6 months
|
|
Psychiatric disorders
Schizophrenia
|
0.72%
2/277 • Up to 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER