Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Interventions
Intramuscular injection, given monthly
Intramuscular injection, given monthly
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Completed the treatment period of Study ALK9072-003EXT * Continues to require chronic treatment with an antipsychotic medication * Continues to reside in a stable living situation * Continues to have an identified reliable informant
Exclusion criteria
* Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug * Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT * Has a significant or unstable medical condition that would preclude safe completion of the current study * Subject is pregnant or breastfeeding * Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) | Up to 12 months | This measure includes all incidences, including those that occurred \>5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time | Up to 12 months | This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period. |
| Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time | Up to 12 months | The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period. |
Countries
Bulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine, United States
Participant flow
Recruitment details
Subjects who successfully completed the treatment period in Study ALK9072-003EXT and continued to meet eligibility criteria were eligible to enroll in this extension study.
Participants by arm
| Arm | Count |
|---|---|
| ALKS 9072, Low ALKS 9072, Low : IM injection, given monthly | 65 |
| ALKS 9072, High ALKS 9072, High: IM injection, given monthly | 226 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Noncompliance with study drug | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Underlying disease | 0 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 14 |
Baseline characteristics
| Characteristic | ALKS 9072, Low | ALKS 9072, High | Total |
|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 11.02 | 40.1 years STANDARD_DEVIATION 11.59 | 39.6 years STANDARD_DEVIATION 11.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 49 Participants | 65 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 19 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 157 Participants | 204 Participants |
| Region of Enrollment Bulgaria | 13 participants | 32 participants | 45 participants |
| Region of Enrollment Malaysia | 1 participants | 17 participants | 18 participants |
| Region of Enrollment Philippines | 15 participants | 27 participants | 42 participants |
| Region of Enrollment Romania | 2 participants | 1 participants | 3 participants |
| Region of Enrollment Russia | 15 participants | 48 participants | 63 participants |
| Region of Enrollment South Korea | 0 participants | 5 participants | 5 participants |
| Region of Enrollment Ukraine | 15 participants | 64 participants | 79 participants |
| Region of Enrollment United States | 4 participants | 32 participants | 36 participants |
| Sex: Female, Male Female | 28 Participants | 107 Participants | 135 Participants |
| Sex: Female, Male Male | 37 Participants | 119 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 226 |
| other Total, other adverse events | 11 / 65 | 26 / 226 |
| serious Total, serious adverse events | 0 / 65 | 4 / 226 |
Outcome results
Primary
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
This measure includes all incidences, including those that occurred \>5%.
Time frame: Up to 12 months
Population: Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALKS 9072, Low | Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) | 21 Participants |
| ALKS 9072, High | Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) | 94 Participants |
Secondary
Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Time frame: Up to 12 months
Population: The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 9072, Low | Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time | -0.7 units on a scale | Standard Deviation 6.73 |
| ALKS 9072, High | Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time | -0.9 units on a scale | Standard Deviation 6.07 |
Secondary
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period.
Time frame: Up to 12 months
Population: The full analysis set consists of all subjects who received at least 1 dost of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALKS 9072, Low | Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time | -0.1 units on a scale | Standard Deviation 0.48 |
| ALKS 9072, High | Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time | -0.1 units on a scale | Standard Deviation 0.52 |