Trial Outcomes & Findings for A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia (NCT NCT02669758)
NCT ID: NCT02669758
Last Updated: 2019-07-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
281 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2019-07-26
Participant Flow
Subjects who completed the 4-week treatment period of the antecedent study, ALK3831-A305, were eligible to be enrolled in Study ALK3831-A306 within 7 days of their last study visit in ALK3831-A305.
A total of 4 subjects enrolled but were not dosed. Three subjects were lost-to-follow-up prior to receiving study drug, and one subject was not compliant with study drug. A total of 277 patients were administered at least one dose of ALKS 3831 and were included in the safety population.
Participant milestones
| Measure |
ALKS 3831
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Overall Study
STARTED
|
277
|
|
Overall Study
COMPLETED
|
183
|
|
Overall Study
NOT COMPLETED
|
94
|
Reasons for withdrawal
| Measure |
ALKS 3831
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
43
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Non-Compliance with Study Drug
|
8
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Study noncompliance
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
ALKS 3831
n=277 Participants
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 11.31 • n=99 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
269 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
218 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
75 Count of participants
n=99 Participants
|
|
Region of Enrollment
Ukraine
|
69 Count of participants
n=99 Participants
|
|
Region of Enrollment
Bulgaria
|
100 Count of participants
n=99 Participants
|
|
Region of Enrollment
Serbia
|
33 Count of participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety population includes all subjects who received at least one dose of study drug.
Outcome measures
| Measure |
ALKS 3831
n=277 Participants
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
136 Participants
|
Adverse Events
ALKS 3831
Serious events: 8 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALKS 3831
n=277 participants at risk
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Psychiatric disorders
Schizophrenia
|
1.8%
5/277 • Number of events 5 • Up to 52 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.36%
1/277 • Number of events 1 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.36%
1/277 • Number of events 1 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.36%
1/277 • Number of events 1 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.36%
1/277 • Number of events 1 • Up to 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.36%
1/277 • Number of events 1 • Up to 52 weeks
|
Other adverse events
| Measure |
ALKS 3831
n=277 participants at risk
Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing
|
|---|---|
|
Investigations
Weight increased
|
13.4%
37/277 • Number of events 40 • Up to 52 weeks
|
|
Investigations
Blood insulin increased
|
2.2%
6/277 • Number of events 6 • Up to 52 weeks
|
|
Investigations
Blood prolactin increased
|
2.2%
6/277 • Number of events 6 • Up to 52 weeks
|
|
Investigations
Weight decreased
|
2.2%
6/277 • Number of events 6 • Up to 52 weeks
|
|
Nervous system disorders
Somnolence
|
8.3%
23/277 • Number of events 27 • Up to 52 weeks
|
|
Nervous system disorders
Headache
|
4.0%
11/277 • Number of events 13 • Up to 52 weeks
|
|
Psychiatric disorders
Anxiety
|
2.5%
7/277 • Number of events 7 • Up to 52 weeks
|
|
Psychiatric disorders
Insomnia
|
2.2%
6/277 • Number of events 6 • Up to 52 weeks
|
|
Psychiatric disorders
Schizophrenia
|
2.2%
6/277 • Number of events 6 • Up to 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
11/277 • Number of events 11 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
3.2%
9/277 • Number of events 11 • Up to 52 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
7/277 • Number of events 9 • Up to 52 weeks
|
|
Social circumstances
Social stay hospitalisation
|
2.5%
7/277 • Number of events 7 • Up to 52 weeks
|
Additional Information
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