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
Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Agrees to use an acceptable method of contraception for the duration of the study * Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days * Additional criteria may apply
Exclusion criteria
* Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine * 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 | Description |
|---|---|---|
| Number of Subjects With Adverse Events | Up to 52 weeks | Overall summary of treatment emergent adverse events during the treatment period |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Subjects that had completed the 24-week treatment period of the antecedent study ALK3831-A303 within seven days prior to enrollment were eligible to be enrolled in the study.
Pre-assignment details
One patient was enrolled and not dosed. A total of 265 patients were administered at least one dose of ALKS 3831 and included in the safety population.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 3831 All subjects assigned to ALKS 3831
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing | 265 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Incarceration | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Non-compliance with study drug | 12 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 8 |
| Overall Study | Withdrawal by Subject | 36 |
Baseline characteristics
| Characteristic | ALKS 3831 |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 9.74 |
| Body Mass Index (BMI) | 26.76 kg/m² STANDARD_DEVIATION 3.756 |
| Body Mass Index (BMI) Group Normal (18.5 to <25) | 85 Participants |
| Body Mass Index (BMI) Group Obese (>=30) | 58 Participants |
| Body Mass Index (BMI) Group Overweight (>=25 to <30) | 121 Participants |
| Body Mass Index (BMI) Group Underweight (<18.5) | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 173.24 centimeters STANDARD_DEVIATION 8.992 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 187 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 192 Participants |
| Weight | 80.64 kilograms STANDARD_DEVIATION 14.698 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 265 |
| other Total, other adverse events | 103 / 265 |
| serious Total, serious adverse events | 5 / 265 |
Outcome results
Primary
Number of Subjects With Adverse Events
Overall summary of treatment emergent adverse events during the treatment period
Time frame: Up to 52 weeks
Population: Safety population was defined as all subjects who received at least one dose of the study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALKS 3831 | Number of Subjects With Adverse Events | Mild Treatment Emergent Adverse Event (TEAE) | 93 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Any Treatment Emergent Adverse Event (TEAE) | 161 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Moderate Treatment- Emergent Adverse Event (TEAE) | 61 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Severe Treatment- Emergent Adverse Event (TEAE) | 7 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Treatment- Emergent Adverse Event (TEAE)-Not Related | 82 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Treatment- Emergent Adverse Event (TEAE)-Related | 79 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Adverse Event Leading to Treatment Discontinuation | 15 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Any Serious Adverse Event (SAE) | 5 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Serious Adverse Event (SAE) -Not Related | 4 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Serious Adverse Event (SAE)-Related | 1 Participants |
| ALKS 3831 | Number of Subjects With Adverse Events | Serious Adverse Event (SAE) leading to Death | 0 Participants |