Trial Outcomes & Findings for A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study (NCT NCT02158533)
NCT ID: NCT02158533
Last Updated: 2019-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
385 participants
Primary outcome timeframe
Baseline and 5 weeks for each stage
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). One subject randomized to the PBO group in Stage 1 did not receive study drug.
Participant milestones
| Measure |
Placebo S1
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
Randomized to ALKS 5461 0.5mg/0.5mg 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 0.5mg/0.5mg S2
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
265
|
59
|
60
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
251
|
51
|
52
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
14
|
8
|
8
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
56
|
56
|
56
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
53
|
52
|
50
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
3
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo S1
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
Randomized to ALKS 5461 0.5mg/0.5mg 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 0.5mg/0.5mg S2
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Stage 1
Adverse Event
|
6
|
4
|
7
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Stage 1
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Lost to Follow-up
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Stage 1
Failure to Meet Eligibility Criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage 1
Non-compliance with study visits
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Stage 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
2
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Stage 2
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Stage 2
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 2
Psychiatrist decision to try new tx
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage 2
Non-adherence with study visits
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Baseline characteristics by cohort
| Measure |
Placebo S1
n=265 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=59 Participants
Randomized to ALKS 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=60 Participants
Randomized to ALKS 5461 2/2 in Stage 1
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 11.50 • n=93 Participants
|
45.0 years
STANDARD_DEVIATION 13.89 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 12.14 • n=27 Participants
|
45.7 years
STANDARD_DEVIATION 11.97 • n=483 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
260 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
124 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
340 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
266 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
32 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
218 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
323 Participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
15 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 5 weeks for each stagePopulation: 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=256 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=58 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=59 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=54 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=55 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=54 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
|
-11.1 units on a scale
Standard Error 0.67
|
-8.4 units on a scale
Standard Error 1.49
|
-13.0 units on a scale
Standard Error 1.50
|
-2.2 units on a scale
Standard Error 1.08
|
-4.8 units on a scale
Standard Error 1.27
|
-3.9 units on a scale
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Baseline and 5 weeks for each stagePopulation: Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.
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 measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).
Outcome measures
| Measure |
Placebo S1
n=256 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=58 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=59 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=54 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=55 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=54 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
No
|
177 Participants
|
49 Participants
|
39 Participants
|
48 Participants
|
46 Participants
|
45 Participants
|
|
Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Yes
|
79 Participants
|
9 Participants
|
20 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and 5 weeks for each stagePopulation: Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.
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=256 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=58 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=59 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=54 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=55 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=54 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Remission Rate
Yes
|
47 Participants
|
6 Participants
|
13 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
|
Remission Rate
No
|
209 Participants
|
52 Participants
|
46 Participants
|
50 Participants
|
48 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 5 weeks for Stage 1 and 6 weeks for Stage 2Population: Safety population consists of all randomized subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo S1
n=265 Participants
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=59 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=60 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=56 Participants
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=56 Participants
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=56 Participants
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
142 Participants
|
34 Participants
|
41 Participants
|
29 Participants
|
27 Participants
|
29 Participants
|
Adverse Events
Placebo S1
Serious events: 1 serious events
Other events: 81 other events
Deaths: 0 deaths
ALKS 5461 0.5mg/0.5mg S1
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S1
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo S2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ALKS 5461 0.5mg/0.5mg S2
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
ALKS 5461 2mg/2mg S2
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo S1
n=265 participants at risk
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=59 participants at risk
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=60 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=56 participants at risk
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=56 participants at risk
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=56 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.38%
1/265 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/59 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/60 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo S1
n=265 participants at risk
Randomized to placebo in Stage 1
|
ALKS 5461 0.5mg/0.5mg S1
n=59 participants at risk
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1
|
ALKS 5461 2mg/2mg S1
n=60 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 1
|
Placebo S2
n=56 participants at risk
Randomized to placebo in Stage 2
|
ALKS 5461 0.5mg/0.5mg S2
n=56 participants at risk
Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2
|
ALKS 5461 2mg/2mg S2
n=56 participants at risk
Randomized to ALKS 5461 2mg/2mg in Stage 2
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.4%
17/265 • Number of events 17 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
23.7%
14/59 • Number of events 15 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
28.3%
17/60 • Number of events 24 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 8 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
4/265 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
6.8%
4/59 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
16.7%
10/60 • Number of events 10 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
4/265 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
6.8%
4/59 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
10.0%
6/60 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
11/265 • Number of events 11 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.4%
2/59 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.9%
5/265 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.1%
3/59 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
6/265 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.7%
1/59 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.3%
2/60 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
6/265 • Number of events 7 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.7%
1/59 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/60 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.38%
1/265 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/59 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.4%
9/265 • Number of events 10 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
6.8%
4/59 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
13.3%
8/60 • Number of events 9 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
2.6%
7/265 • Number of events 7 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.5%
5/59 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
10.0%
6/60 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
22/265 • Number of events 23 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
11.9%
7/59 • Number of events 10 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sedation
|
1.1%
3/265 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
3.4%
2/59 • Number of events 2 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 6 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.6%
7/265 • Number of events 7 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.7%
1/59 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
8.3%
5/60 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
2.6%
7/265 • Number of events 7 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.1%
3/59 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/265 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/59 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
4/265 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/59 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
6.7%
4/60 • Number of events 4 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
1.9%
5/265 • Number of events 5 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/59 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
5.0%
3/60 • Number of events 3 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
0.00%
0/56 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • 5 weeks for Stage 1 and 6 weeks for Stage 2
Safety population consists of all randomized subjects who 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