Trial Outcomes & Findings for An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070) (NCT NCT01895452)
NCT ID: NCT01895452
Last Updated: 2017-08-25
Results Overview
This measure includes all incidences, including those that occurred \>5%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2017-08-25
Participant Flow
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.
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
|
65
|
226
|
|
Overall Study
COMPLETED
|
61
|
198
|
|
Overall Study
NOT COMPLETED
|
4
|
28
|
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
Adverse Event
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
14
|
|
Overall Study
Underlying disease
|
0
|
3
|
|
Overall Study
Noncompliance with study drug
|
0
|
1
|
Baseline Characteristics
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Baseline characteristics by cohort
| Measure |
ALKS 9072, Low
n=65 Participants
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=226 Participants
ALKS 9072, High: IM injection, given monthly
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 11.59 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
156 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
|
16 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
204 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
South Korea
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
32 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
15 participants
n=5 Participants
|
27 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
15 participants
n=5 Participants
|
64 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=5 Participants
|
17 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
13 participants
n=5 Participants
|
32 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
15 participants
n=5 Participants
|
48 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.
This measure includes all incidences, including those that occurred \>5%.
Outcome measures
| Measure |
ALKS 9072, Low
n=65 Participants
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=226 Participants
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
|
21 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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); 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.
Outcome measures
| Measure |
ALKS 9072, Low
n=65 Participants
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=221 Participants
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
|
-0.7 units on a scale
Standard Deviation 6.73
|
-0.9 units on a scale
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
ALKS 9072, Low
n=65 Participants
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=221 Participants
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
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
|
-0.1 units on a scale
Standard Deviation 0.52
|
Adverse Events
ALKS 9072, Low
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ALKS 9072, High
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALKS 9072, Low
n=65 participants at risk
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=226 participants at risk
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/65 • Adverse events were collected at every study visit for up to 35 months.
|
0.44%
1/226 • Number of events 1 • Adverse events were collected at every study visit for up to 35 months.
|
Other adverse events
| Measure |
ALKS 9072, Low
n=65 participants at risk
ALKS 9072, Low : IM injection, given monthly
|
ALKS 9072, High
n=226 participants at risk
ALKS 9072, High: IM injection, given monthly
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
4/65 • Number of events 4 • Adverse events were collected at every study visit for up to 35 months.
|
3.1%
7/226 • Number of events 8 • Adverse events were collected at every study visit for up to 35 months.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
4/65 • Number of events 4 • Adverse events were collected at every study visit for up to 35 months.
|
1.3%
3/226 • Number of events 4 • Adverse events were collected at every study visit for up to 35 months.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
4/65 • Number of events 4 • Adverse events were collected at every study visit for up to 35 months.
|
4.0%
9/226 • Number of events 11 • Adverse events were collected at every study visit for up to 35 months.
|
|
Psychiatric disorders
Insomnia
|
3.1%
2/65 • Number of events 4 • Adverse events were collected at every study visit for up to 35 months.
|
7.1%
16/226 • Number of events 20 • Adverse events were collected at every study visit for up to 35 months.
|
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