Trial Outcomes & Findings for A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) (NCT NCT01626456)
NCT ID: NCT01626456
Last Updated: 2018-09-25
Results Overview
This measure includes incidences \>5%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
52 weeks
Results posted on
2018-09-25
Participant Flow
Subjects who successfully completed the Day 85 visit in Study ALK9072-003 and continued to meet eligibility criteria were eligible to enroll in this extension study. In addition, adults with chronic stable schizophrenia on a stable oral antipsychotic medication not previously enrolled in Study ALK9072-003 were also eligible to enroll.
While there were only 2 treatment groups in this extension study (low dose and high dose), data for several outcome measures is presented by lead-in study groups, and separated into 5 categories: PBO-441 mg, 441-441 mg, PBO-882 mg, 882-882 mg, and de novo.
Participant milestones
| Measure |
ALKS 9072, Low
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
368
|
|
Overall Study
COMPLETED
|
75
|
251
|
|
Overall Study
NOT COMPLETED
|
35
|
117
|
Reasons for withdrawal
| Measure |
ALKS 9072, Low
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
21
|
46
|
|
Overall Study
Adverse Event
|
2
|
27
|
|
Overall Study
Lost to Follow-up
|
2
|
27
|
|
Overall Study
Lack of Efficacy
|
6
|
7
|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Site Closure
|
2
|
3
|
|
Overall Study
Incarceration
|
0
|
2
|
Baseline Characteristics
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Baseline characteristics by cohort
| Measure |
ALKS 9072, Low
n=110 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=368 Participants
ALKS 9072, High: IM injection, given monthly
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
20 participants
n=5 Participants
|
60 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
111 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
17 participants
n=5 Participants
|
32 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
29 participants
n=5 Participants
|
93 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
3 participants
n=5 Participants
|
21 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
19 participants
n=5 Participants
|
43 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.
This measure includes incidences \>5%.
Outcome measures
| Measure |
ALKS 9072, Low
n=110 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=368 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
Subjects who received high dose in both the base study and the current study.
|
De Novo
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
|
51 participants
|
190 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.
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.
Outcome measures
| Measure |
ALKS 9072, Low
n=29 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=80 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
n=26 Participants
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
n=94 Participants
Subjects who received high dose in both the base study and the current study.
|
De Novo
n=233 Participants
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
|
-0.9 units on a scale
Standard Deviation 0.68
|
-0.5 units on a scale
Standard Deviation 0.71
|
-0.8 units on a scale
Standard Deviation 0.85
|
-0.3 units on a scale
Standard Deviation 0.61
|
-0.2 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.
Number of subjects who discontinued the study due to AE.
Outcome measures
| Measure |
ALKS 9072, Low
n=110 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=368 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
Subjects who received high dose in both the base study and the current study.
|
De Novo
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Discontinuation From Study Due to Adverse Events (AEs)
|
2 participants
|
27 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.
The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
Outcome measures
| Measure |
ALKS 9072, Low
n=29 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=81 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
n=26 Participants
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
n=100 Participants
Subjects who received high dose in both the base study and the current study.
|
De Novo
n=242 Participants
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Any suicidal ideation
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
|
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Any suicidal behavior
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 52 weeksIncludes incidence \>2% but \<5%.
Outcome measures
| Measure |
ALKS 9072, Low
n=29 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=81 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
n=26 Participants
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
n=100 Participants
Subjects who received high dose in both the base study and the current study.
|
De Novo
n=242 Participants
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Tremor
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
7 participants
|
|
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Glycosylated haemoglobin increased
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Hypertension
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
4 participants
|
|
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests
Akathisia
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: 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.
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), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
Outcome measures
| Measure |
ALKS 9072, Low
n=29 Participants
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=80 Participants
ALKS 9072, High: IM injection, given monthly
|
PBO-882 mg
n=26 Participants
Subjects who received placebo in the base study and high dose in the current study.
|
882-882 mg
n=94 Participants
Subjects who received high dose in both the base study and the current study.
|
De Novo
n=233 Participants
Subjects who did not participate in the base study. These subjects received high dose.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
Positive Subscale Score
|
-5.8 units on a scale
Standard Deviation 6.0
|
-3.4 units on a scale
Standard Deviation 3.4
|
-4.1 units on a scale
Standard Deviation 4.1
|
-2.3 units on a scale
Standard Deviation 3.1
|
-1.8 units on a scale
Standard Deviation 2.8
|
|
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
Total Score
|
-19.1 units on a scale
Standard Deviation 15.5
|
-10.0 units on a scale
Standard Deviation 10.2
|
-11.6 units on a scale
Standard Deviation 11.7
|
-8.3 units on a scale
Standard Deviation 8.2
|
-5.9 units on a scale
Standard Deviation 8.3
|
|
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
Negative Subscale Score
|
-4.1 units on a scale
Standard Deviation 4.2
|
-1.5 units on a scale
Standard Deviation 3.5
|
-1.6 units on a scale
Standard Deviation 3.8
|
-2.1 units on a scale
Standard Deviation 3.0
|
-1.2 units on a scale
Standard Deviation 3.3
|
|
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores
General Psychopathology Subscale Score
|
-9.2 units on a scale
Standard Deviation 7.6
|
-5.1 units on a scale
Standard Deviation 5.6
|
-5.9 units on a scale
Standard Deviation 6.1
|
-4.0 units on a scale
Standard Deviation 4.7
|
-2.9 units on a scale
Standard Deviation 4.7
|
Adverse Events
ALKS 9072, Low
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
ALKS 9072, High
Serious events: 15 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALKS 9072, Low
n=110 participants at risk
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=368 participants at risk
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.54%
2/368 • Number of events 2 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Aggression
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Somatoform disorder cardiovascular
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.54%
2/368 • Number of events 2 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/110 • Adverse events were collected at every study visit for 1 year (365 days).
|
0.27%
1/368 • Number of events 1 • Adverse events were collected at every study visit for 1 year (365 days).
|
Other adverse events
| Measure |
ALKS 9072, Low
n=110 participants at risk
ALKS 9072, Low: IM injection, given monthly
|
ALKS 9072, High
n=368 participants at risk
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Investigations
Weight increased
|
6.4%
7/110 • Number of events 8 • Adverse events were collected at every study visit for 1 year (365 days).
|
4.6%
17/368 • Number of events 17 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Nervous system disorders
Headache
|
6.4%
7/110 • Number of events 10 • Adverse events were collected at every study visit for 1 year (365 days).
|
3.0%
11/368 • Number of events 15 • Adverse events were collected at every study visit for 1 year (365 days).
|
|
Psychiatric disorders
Insomnia
|
2.7%
3/110 • Number of events 4 • Adverse events were collected at every study visit for 1 year (365 days).
|
10.1%
37/368 • Number of events 45 • Adverse events were collected at every study visit for 1 year (365 days).
|
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