Trial Outcomes & Findings for A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study (NCT NCT02218008)
NCT ID: NCT02218008
Last Updated: 2019-08-14
Results Overview
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
Results posted on
2019-08-14
Participant Flow
Subjects were diagnosed with major depressive disorder (MDD), and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.
This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). 1 subject randomized to the placebo group in Stage 1 did not receive any study drug.
Participant milestones
| Measure |
Placebo S1
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1 (S1)
STARTED
|
280
|
63
|
63
|
0
|
0
|
0
|
|
Stage 1 (S1)
COMPLETED
|
258
|
56
|
48
|
0
|
0
|
0
|
|
Stage 1 (S1)
NOT COMPLETED
|
22
|
7
|
15
|
0
|
0
|
0
|
|
Stage 2 (S2)
STARTED
|
0
|
0
|
0
|
62
|
62
|
63
|
|
Stage 2 (S2)
COMPLETED
|
0
|
0
|
0
|
58
|
58
|
57
|
|
Stage 2 (S2)
NOT COMPLETED
|
0
|
0
|
0
|
4
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo S1
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1 (S1)
Adverse Event
|
6
|
5
|
11
|
0
|
0
|
0
|
|
Stage 1 (S1)
Withdrawal by Subject
|
6
|
1
|
1
|
0
|
0
|
0
|
|
Stage 1 (S1)
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 (S1)
Lost to Follow-up
|
3
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1 (S1)
Non-compliance with Study Drug
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Stage 1 (S1)
Non-compliance; drug use
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1 (S1)
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1 (S1)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 1 (S1)
Failure to Meet Eligibility Criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2 (S2)
Adverse Event
|
0
|
0
|
0
|
2
|
3
|
3
|
|
Stage 2 (S2)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Stage 2 (S2)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Stage 2 (S2)
Failure to Meet Eligibility Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 2 (S2)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Baseline characteristics by cohort
| Measure |
Placebo
n=280 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg
n=63 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.87 • n=99 Participants
|
45.1 years
STANDARD_DEVIATION 11.46 • n=107 Participants
|
42.9 years
STANDARD_DEVIATION 14.48 • n=206 Participants
|
45.2 years
STANDARD_DEVIATION 12.93 • n=7 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
277 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
339 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
301 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
229 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
335 Participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
46 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effectPopulation: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS assessment in the respective stage.
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Outcome measures
| Measure |
Placebo S1
n=273 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=60 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
|
-5.6 Units on a scale
Standard Error 0.34
|
-6.0 Units on a scale
Standard Error 0.74
|
-6.8 Units on a scale
Standard Error 0.75
|
-1.5 Units on a scale
Standard Error 0.65
|
-2.2 Units on a scale
Standard Error 0.67
|
-3.2 Units on a scale
Standard Error 0.67
|
PRIMARY outcome
Timeframe: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Outcome measures
| Measure |
Placebo S1
n=273 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=60 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
|
-8.1 Units on a scale
Standard Error 0.48
|
-8.8 Units on a scale
Standard Error 1.05
|
-10.3 Units on a scale
Standard Error 1.06
|
-2.1 Units on a scale
Standard Error 0.88
|
-3.2 Units on a scale
Standard Error 0.91
|
-3.7 Units on a scale
Standard Error 0.90
|
PRIMARY outcome
Timeframe: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Outcome measures
| Measure |
Placebo S1
n=273 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=60 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change From Baseline to End of Treatment in the MADRS-10
|
-9.2 Units on a scale
Standard Error 0.55
|
-10.3 Units on a scale
Standard Error 1.19
|
-10.8 Units on a scale
Standard Error 1.22
|
-1.9 Units on a scale
Standard Error 0.96
|
-3.4 Units on a scale
Standard Error 0.98
|
-3.6 Units on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.
The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Outcome measures
| Measure |
Placebo S1
n=273 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=60 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Yes
|
61 Participants
|
17 Participants
|
16 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
No
|
212 Participants
|
45 Participants
|
47 Participants
|
53 Participants
|
55 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)Population: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 (or HAM-D17) assessment in the respective stage.
The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.
Outcome measures
| Measure |
Placebo S1
n=273 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=60 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Remission Rate
Yes
|
31 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Remission Rate
No
|
242 Participants
|
54 Participants
|
55 Participants
|
56 Participants
|
56 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)Population: The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo S1
n=280 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=63 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=62 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 Participants
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
151 Participants
|
37 Participants
|
42 Participants
|
25 Participants
|
29 Participants
|
25 Participants
|
Adverse Events
Placebo S1
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
ALKS 5461 1mg/1mg S1
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S1
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo S2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
ALKS 5461 1mg/1mg S2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo S1
n=280 participants at risk
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=63 participants at risk
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=62 participants at risk
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 participants at risk
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.36%
1/280 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/280 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/280 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/280 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo S1
n=280 participants at risk
Randomized to placebo in Stage 1
|
ALKS 5461 1mg/1mg S1
n=63 participants at risk
Randomized to ALKS 5461 1mg/1mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=63 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=62 participants at risk
Randomized to placebo in Stage 2
|
ALKS 5461 1mg/1mg S2
n=62 participants at risk
Randomized to ALKS 5461 1mg/1mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=63 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
20/280 • Number of events 21 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
14.3%
9/63 • Number of events 11 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
27.0%
17/63 • Number of events 20 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
7.9%
5/63 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.3%
12/280 • Number of events 13 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
9.5%
6/63 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
11.1%
7/63 • Number of events 7 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.36%
1/280 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
7.9%
5/63 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
11.1%
7/63 • Number of events 8 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
7/280 • Number of events 8 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
4.8%
3/63 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
9.5%
6/63 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/62 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
9/280 • Number of events 10 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
14.3%
9/63 • Number of events 10 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
7.9%
5/63 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
6.3%
4/63 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.9%
22/280 • Number of events 23 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
6.3%
4/63 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
7.9%
5/63 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
8/280 • Number of events 8 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
4.8%
3/63 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
6.5%
4/62 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
3.2%
2/62 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
4.3%
12/280 • Number of events 12 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
6.3%
4/63 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
4.8%
3/63 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/62 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
0.00%
0/63 • 5 weeks for Stage 1 and 6 weeks for Stage 2
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
|
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