Schizophrenia
Conditions
Keywords
Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Brief summary
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Interventions
DRUGALKS 3831
Tablets were administered for daily dosing
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days. * Agrees to use an acceptable method of contraception for the duration of the study. * Additional criteria may apply.
Exclusion criteria
* Subject is currently taking medications that are contraindicated with olanzapine use. * Subject has a positive test for drugs of abuse at study entry. * Subject is pregnant, planning to become pregnant, or breastfeeding during the study. * Additional criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 52 weeks |
Countries
Bulgaria, Serbia, Ukraine, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 3831 Administered as a coated bilayer tablet.
ALKS 3831: Daily dosing | 277 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 19 |
| Overall Study | Non-Compliance with Study Drug | 8 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study noncompliance | 1 |
| Overall Study | Withdrawal by Subject | 43 |
Baseline characteristics
| Characteristic | ALKS 3831 |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 11.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 269 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 218 Participants |
| Region of Enrollment Bulgaria | 100 Count of participants |
| Region of Enrollment Serbia | 33 Count of participants |
| Region of Enrollment Ukraine | 69 Count of participants |
| Region of Enrollment United States | 75 Count of participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 277 |
| other Total, other adverse events | 102 / 277 |
| serious Total, serious adverse events | 8 / 277 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
Time frame: Up to 52 weeks
Population: Safety population includes all subjects who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALKS 3831 | Number of Participants With Adverse Events (AEs) | 136 Participants |