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Trial record 69 of 890 for:    "Depressive Disorder" [DISEASE] AND MADRS

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

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ClinicalTrials.gov Identifier: NCT02218008
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : March 27, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: ALKS 5461
Drug: Placebo
Enrollment 407
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description Randomized to placebo in Stage 1 Randomized to ALKS 5461 1mg/1mg in Stage 1 Randomized to ALKS 5461 2mg/2mg in Stage 1 Randomized to placebo in Stage 2 Randomized to ALKS 5461 1mg/1mg in Stage 2 Randomized to ALKS 5461 2mg/2mg in Stage 2
Period Title: Stage 1 (S1)
Started 280 63 63 0 0 0
Completed 258 56 48 0 0 0
Not Completed 22 7 15 0 0 0
Reason Not Completed
Adverse Event             6             5             11             0             0             0
Withdrawal by Subject             6             1             1             0             0             0
Lack of Efficacy             3             0             0             0             0             0
Lost to Follow-up             3             0             1             0             0             0
Non-compliance with Study Drug             2             1             0             0             0             0
Non-compliance; drug use             1             0             0             0             0             0
Pregnancy             0             0             1             0             0             0
Protocol Violation             0             0             1             0             0             0
Failure to Meet Eligibility Criteria             1             0             0             0             0             0
Period Title: Stage 2 (S2)
Started [1] 0 0 0 62 62 63
Completed 0 0 0 58 58 57
Not Completed 0 0 0 4 4 6
Reason Not Completed
Adverse Event             0             0             0             2             3             3
Withdrawal by Subject             0             0             0             1             1             0
Lack of Efficacy             0             0             0             0             0             2
Failure to Meet Eligibility Criteria             0             0             0             1             0             0
Lost to Follow-up             0             0             0             0             0             1
[1]
Subjects randomized in Stage 2 are a subset of those randomized to placebo in Stage 1.
Arm/Group Title Placebo ALKS 5461 1mg/1mg ALKS 5461 2mg/2mg Total
Hide Arm/Group Description Randomized to placebo in Stage 1 Randomized to ALKS 5461 1mg/1mg in Stage 1 Randomized to ALKS 5461 2mg/2mg in Stage 1 Total of all reporting groups
Overall Number of Baseline Participants 280 63 63 406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 280 participants 63 participants 63 participants 406 participants
45.7  (12.87) 45.1  (11.46) 42.9  (14.48) 45.2  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 63 participants 63 participants 406 participants
Female
193
  68.9%
42
  66.7%
42
  66.7%
277
  68.2%
Male
87
  31.1%
21
  33.3%
21
  33.3%
129
  31.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 63 participants 63 participants 406 participants
Hispanic or Latino
48
  17.1%
10
  15.9%
9
  14.3%
67
  16.5%
Not Hispanic or Latino
232
  82.9%
53
  84.1%
54
  85.7%
339
  83.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 63 participants 63 participants 406 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
5
   1.8%
2
   3.2%
2
   3.2%
9
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
67
  23.9%
17
  27.0%
11
  17.5%
95
  23.4%
White
207
  73.9%
44
  69.8%
50
  79.4%
301
  74.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 63 participants 63 participants 406 participants
Canada
5
   1.8%
1
   1.6%
1
   1.6%
7
   1.7%
United States
229
  81.8%
54
  85.7%
52
  82.5%
335
  82.5%
Germany
46
  16.4%
8
  12.7%
10
  15.9%
64
  15.8%
1.Primary Outcome
Title 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)
Hide Description 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).
Time Frame Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 273 62 63 60 62 63
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.6  (0.34) -6.0  (0.74) -6.8  (0.75) -1.5  (0.65) -2.2  (0.67) -3.2  (0.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo S1, ALKS 5461 2mg/2mg S1, Placebo S2, ALKS 5461 2mg/2mg S2
Comments Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.
Method Mixed Models Analysis
Comments ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.7 to -0.3
Estimation Comments Estimates below zero favor ALKS 5461.
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 273 62 63 60 62 63
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.1  (0.48) -8.8  (1.05) -10.3  (1.06) -2.1  (0.88) -3.2  (0.91) -3.7  (0.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo S1, ALKS 5461 2mg/2mg S1, Placebo S2, ALKS 5461 2mg/2mg S2
Comments Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.
Type of Statistical Test Superiority
Comments Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.
Statistical Test of Hypothesis P-Value 0.026
Comments ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.6 to -0.2
Estimation Comments Estimates below zero favor ALKS 5461.
3.Primary Outcome
Title Change From Baseline to End of Treatment in the MADRS-10
Hide Description 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.
Time Frame 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 273 62 63 60 62 63
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-9.2  (0.55) -10.3  (1.19) -10.8  (1.22) -1.9  (0.96) -3.4  (0.98) -3.6  (0.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo S1, ALKS 5461 2mg/2mg S1, Placebo S2, ALKS 5461 2mg/2mg S2
Comments ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.
Type of Statistical Test Superiority
Comments The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.
Statistical Test of Hypothesis P-Value 0.076
Comments ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-3.6 to 0.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Hide Description 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.
Time Frame 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 273 62 63 60 62 63
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
61
  22.3%
17
  27.4%
16
  25.4%
7
  11.7%
7
  11.3%
6
   9.5%
No
212
  77.7%
45
  72.6%
47
  74.6%
53
  88.3%
55
  88.7%
57
  90.5%
5.Secondary Outcome
Title Remission Rate
Hide Description The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.
Time Frame 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 273 62 63 60 62 63
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
31
  11.4%
8
  12.9%
8
  12.7%
4
   6.7%
6
   9.7%
5
   7.9%
No
242
  88.6%
54
  87.1%
55
  87.3%
56
  93.3%
56
  90.3%
58
  92.1%
6.Secondary Outcome
Title Number of Subjects With Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description:
Randomized to placebo in Stage 1
Randomized to ALKS 5461 1mg/1mg in Stage 1
Randomized to ALKS 5461 2mg/2mg in Stage 1
Randomized to placebo in Stage 2
Randomized to ALKS 5461 1mg/1mg in Stage 2
Randomized to ALKS 5461 2mg/2mg in Stage 2
Overall Number of Participants Analyzed 280 63 63 62 62 63
Measure Type: Count of Participants
Unit of Measure: Participants
151
  53.9%
37
  58.7%
42
  66.7%
25
  40.3%
29
  46.8%
25
  39.7%
Time Frame 5 weeks for Stage 1 and 6 weeks for Stage 2
Adverse Event Reporting Description The safety population includes all subjects who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Hide Arm/Group Description Randomized to placebo in Stage 1 Randomized to ALKS 5461 1mg/1mg in Stage 1 Randomized to ALKS 5461 2mg/2mg in Stage 1 Randomized to placebo in Stage 2 Randomized to ALKS 5461 1mg/1mg in Stage 2 Randomized to ALKS 5461 2mg/2mg in Stage 2
All-Cause Mortality
Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/280 (0.00%)      0/63 (0.00%)      0/63 (0.00%)      0/62 (0.00%)      0/62 (0.00%)      0/63 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/280 (0.36%)      0/63 (0.00%)      2/63 (3.17%)      1/62 (1.61%)      0/62 (0.00%)      0/63 (0.00%)    
Gastrointestinal disorders             
Abdominal Pain * 1  1/280 (0.36%)  1 0/63 (0.00%)  0 0/63 (0.00%)  0 0/62 (0.00%)  0 0/62 (0.00%)  0 0/63 (0.00%)  0
Injury, poisoning and procedural complications             
Wrist Fracture * 1  0/280 (0.00%)  0 0/63 (0.00%)  0 1/63 (1.59%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0 0/63 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Muscle strain * 1  0/280 (0.00%)  0 0/63 (0.00%)  0 1/63 (1.59%)  1 0/62 (0.00%)  0 0/62 (0.00%)  0 0/63 (0.00%)  0
Psychiatric disorders             
Suicide Attempt * 1  0/280 (0.00%)  0 0/63 (0.00%)  0 0/63 (0.00%)  0 1/62 (1.61%)  1 0/62 (0.00%)  0 0/63 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo S1 ALKS 5461 1mg/1mg S1 ALKS 5461 2mg/2mg S1 Placebo S2 ALKS 5461 1mg/1mg S2 ALKS 5461 2mg/2mg S2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/280 (25.71%)      25/63 (39.68%)      28/63 (44.44%)      11/62 (17.74%)      6/62 (9.68%)      10/63 (15.87%)    
Gastrointestinal disorders             
Nausea * 1  20/280 (7.14%)  21 9/63 (14.29%)  11 17/63 (26.98%)  20 1/62 (1.61%)  1 2/62 (3.23%)  2 5/63 (7.94%)  5
Vomiting * 1  7/280 (2.50%)  8 3/63 (4.76%)  3 6/63 (9.52%)  6 1/62 (1.61%)  1 0/62 (0.00%)  0 1/63 (1.59%)  2
Constipation * 1  9/280 (3.21%)  10 9/63 (14.29%)  10 5/63 (7.94%)  5 0/62 (0.00%)  0 2/62 (3.23%)  2 4/63 (6.35%)  4
General disorders             
Fatigue * 1  1/280 (0.36%)  1 5/63 (7.94%)  5 7/63 (11.11%)  8 1/62 (1.61%)  1 0/62 (0.00%)  0 1/63 (1.59%)  1
Infections and infestations             
Nasopharyngitis * 1  8/280 (2.86%)  8 1/63 (1.59%)  1 3/63 (4.76%)  3 4/62 (6.45%)  4 2/62 (3.23%)  2 1/63 (1.59%)  1
Nervous system disorders             
Dizziness * 1  12/280 (4.29%)  13 6/63 (9.52%)  6 7/63 (11.11%)  7 1/62 (1.61%)  1 1/62 (1.61%)  1 2/63 (3.17%)  2
Headache * 1  22/280 (7.86%)  23 4/63 (6.35%)  5 5/63 (7.94%)  5 4/62 (6.45%)  6 0/62 (0.00%)  0 2/63 (3.17%)  2
Somnolence * 1  12/280 (4.29%)  12 4/63 (6.35%)  4 3/63 (4.76%)  3 0/62 (0.00%)  0 0/62 (0.00%)  0 0/63 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eva Stroynowski
Organization: Alkermes, Inc.
Phone: 781-609-7000
EMail: eva.stroynowski@alkermes.com
Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02218008     History of Changes
Other Study ID Numbers: ALK5461-207
First Submitted: August 14, 2014
First Posted: August 15, 2014
Results First Submitted: March 1, 2019
Results First Posted: March 27, 2019
Last Update Posted: August 14, 2019