Bipolar I Disorder, Schizophrenia, Schizophreniform Disorder
Conditions
Keywords
Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
Brief summary
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
Interventions
DRUGALKS 3831
Olanzapine + samidorphan, daily oral dosing
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to give informed consent/assent as per local requirements * Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal * Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator * Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307 * Additional criteria may apply
Exclusion criteria
* Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements * Has a positive drug screen for drugs of abuse at study entry * Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Up to 48 months | — |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale | Up to 48 months | The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients |
Countries
Austria, Bulgaria, Ireland, Israel, Italy, Poland, Puerto Rico, Russia, Serbia, South Korea, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALKS 3831 Coated bilayer tablet
ALKS 3831: Olanzapine + samidorphan, daily oral dosing | 523 |
| Total | 523 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 44 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Logistical Difficulties Due to Regional Wars & COVID-19 | 72 |
| Overall Study | Lost to Follow-up | 37 |
| Overall Study | Not Yet Determined | 5 |
| Overall Study | Other | 20 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 20 |
| Overall Study | Study Terminated at Site by Sponsor Due to Regional War | 1 |
| Overall Study | Withdrawal by Subject | 133 |
Baseline characteristics
| Characteristic | ALKS 3831 |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 12.16 |
| Body Mass Index | 26.00 kg/m^2 STANDARD_DEVIATION 4.332 |
| Clinical Global Impression-Severity | 3.06 units on a scale STANDARD_DEVIATION 0.867 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 504 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 172.28 Centimeters STANDARD_DEVIATION 9.481 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 126 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 380 Participants |
| Region of Enrollment Austria | 2 participants |
| Region of Enrollment Bulgaria | 63 participants |
| Region of Enrollment Ireland | 2 participants |
| Region of Enrollment Israel | 28 participants |
| Region of Enrollment Italy | 4 participants |
| Region of Enrollment Poland | 2 participants |
| Region of Enrollment Russia | 69 participants |
| Region of Enrollment Serbia | 25 participants |
| Region of Enrollment South Korea | 2 participants |
| Region of Enrollment Ukraine | 118 participants |
| Region of Enrollment United Kingdom | 2 participants |
| Region of Enrollment United States | 206 participants |
| Sex: Female, Male Female | 201 Participants |
| Sex: Female, Male Male | 322 Participants |
| Weight | 77.39 kilograms STANDARD_DEVIATION 15.486 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 523 |
| other Total, other adverse events | 314 / 523 |
| serious Total, serious adverse events | 35 / 523 |
Outcome results
Primary
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
Time frame: Up to 48 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 3831 | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale | -.24 units on a scale | Standard Deviation 0.651 |
Primary
Incidence of Adverse Events
Time frame: Up to 48 months
Population: All enrolled participants who received at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALKS 3831 | Incidence of Adverse Events | 314 Participants |