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A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01500200
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : May 21, 2019
Last Update Posted : May 21, 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 142
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). One subject randomized to placebo did not receive study drug.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description Received placebo in Stage 1 Received ALKS 5461 2mg/2mg in Stage 1 Received ALKS 5461 8mg/8mg in Stage 1 Received placebo in Stage 2 Received ALKS 5461 2mg/2mg in Stage 2 Received ALKS 5461 8mg/8mg in Stage 2
Period Title: Stage 1
Started 98 24 19 0 0 0
Completed 90 18 13 0 0 0
Not Completed 8 6 6 0 0 0
Reason Not Completed
Adverse Event             1             4             5             0             0             0
Lost to Follow-up             2             2             1             0             0             0
Withdrawal by Subject             3             0             0             0             0             0
Noncompliance with Study Drug             1             0             0             0             0             0
Physician Decision             1             0             0             0             0             0
Period Title: Stage 2
Started [1] 0 0 0 20 23 22
Completed 0 0 0 20 18 18
Not Completed 0 0 0 0 5 4
Reason Not Completed
Adverse Event             0             0             0             0             5             4
[1]
Subjects in Stage 2 are a subset of those randomized to placebo in Stage 1.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Total
Hide Arm/Group Description Received placebo in Stage 1 Received ALKS 5461 2mg/2mg in Stage 1 Received ALKS 5461 8mg/8mg in Stage 1 Total of all reporting groups
Overall Number of Baseline Participants 98 24 19 141
Hide Baseline Analysis Population Description
All subjects randomized to Stage 1 (i.e., all subjects randomized during the study) who received ≥ dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 24 participants 19 participants 141 participants
46.6  (11.0) 45.2  (10.9) 45.8  (11.9) 46.3  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 24 participants 19 participants 141 participants
Female
68
  69.4%
17
  70.8%
11
  57.9%
96
  68.1%
Male
30
  30.6%
7
  29.2%
8
  42.1%
45
  31.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 24 participants 19 participants 141 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.7%
Black or African American
23
  23.5%
9
  37.5%
6
  31.6%
38
  27.0%
White
74
  75.5%
15
  62.5%
13
  68.4%
102
  72.3%
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: Number
Unit of measure:  Count of participants
United States Number Analyzed 98 participants 24 participants 19 participants 141 participants
98 24 19 141
1.Primary Outcome
Title Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score
Hide Description The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Time Frame Baseline and 4 weeks for each stage
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 HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description:
Subjects randomized to placebo in Stage 1
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
Subjects randomized to placebo in Stage 2
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
Overall Number of Participants Analyzed 95 20 20 20 23 22
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-7.1  (0.6) -9.3  (1.5) -6.6  (1.6) -1.5  (1.1) -5.2  (1.2) -3.3  (1.1)
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 weights (0.6/0.4 for Stage 1/Stage 2). 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments Hypothesis tests were two-sided with an alpha of 0.5.
Method Mixed Models Analysis
Comments ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo S1, ALKS 5461 8mg/8mg S1, Placebo S2, ALKS 5461 8mg/8mg 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 weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments Hypothesis tests were two-sided with an alpha of 0.05.
Method Mixed Models Analysis
Comments ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.
2.Secondary Outcome
Title Proportion of Patients Who Exhibited Treatment Response (HAM-D17)
Hide Description The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.
Time Frame 4 weeks for each stage
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 HAM-D17 assessment in the respective stage.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description:
Subjects randomized to placebo in Stage 1
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
Subjects randomized to placebo in Stage 2
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
Overall Number of Participants Analyzed 90 17 14 20 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
23
  25.6%
8
  47.1%
5
  35.7%
3
  15.0%
6
  33.3%
5
  27.8%
No
67
  74.4%
9
  52.9%
9
  64.3%
17
  85.0%
12
  66.7%
13
  72.2%
3.Secondary Outcome
Title Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
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 4 weeks for each stage
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 HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description:
Subjects randomized to placebo in Stage 1
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
Subjects randomized to placebo in Stage 2
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
Overall Number of Participants Analyzed 95 20 20 20 23 22
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-9.6  (0.9) -13.3  (2.2) -11.3  (2.3) -2.1  (1.6) -8.8  (1.7) -4.7  (1.7)
4.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score
Hide Description The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: “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.”
Time Frame 4 weeks for each stage
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 HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description:
Subjects randomized to placebo in Stage 1
Subjects randomized to ALKS 5461 2mg/2mg in Stage 1
Subjects randomized to ALKS 5461 8mg/8mg in Stage 1
Subjects randomized to placebo in Stage 2
Subjects randomized to ALKS 5461 2mg/2mg in Stage 2
Subjects randomized to ALKS 5461 8mg/8mg in Stage 2
Overall Number of Participants Analyzed 95 20 20 20 23 22
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.0  (0.1) -1.3  (0.2) -1.2  (0.3) -0.5  (0.2) -1.1  (0.2) -0.6  (0.2)
Time Frame 4 weeks for each stage
Adverse Event Reporting Description The safety population includes all subjects who were randomized and received at least 1 dose of study drug. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 2/2 group for the safety analysis.
 
Arm/Group Title Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Hide Arm/Group Description Received placebo in Stage 1 Received ALKS 5461 2mg/2mg in Stage 1 Received ALKS 5461 8mg/8mg in Stage 1 Received placebo in Stage 2 Received ALKS 5461 2mg/2mg in Stage 1 Received ALKS 5461 8mg/8mg in Stage 1
All-Cause Mortality
Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg S2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)      0/24 (0.00%)      0/19 (0.00%)      0/20 (0.00%)      0/23 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo S1 ALKS 5461 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg 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   1/98 (1.02%)      1/24 (4.17%)      0/19 (0.00%)      0/20 (0.00%)      1/23 (4.35%)      0/22 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Intraocular melanoma * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Psychiatric disorders             
Multiple drug overdose intentional * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Drug withdrawal syndrome * 1  0/98 (0.00%)  0 1/24 (4.17%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
*
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 2mg/2mg S1 ALKS 5461 8mg/8mg S1 Placebo S2 ALKS 5461 2mg/2mg S2 ALKS 5461 8mg/8mg 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   42/98 (42.86%)      15/24 (62.50%)      18/19 (94.74%)      11/20 (55.00%)      19/23 (82.61%)      17/22 (77.27%)    
Eye disorders             
Dry eye * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Miosis * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Vision blurred * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Gastrointestinal disorders             
Nausea * 1  6/98 (6.12%)  7 5/24 (20.83%)  6 9/19 (47.37%)  10 2/20 (10.00%)  2 10/23 (43.48%)  11 5/22 (22.73%)  5
Constipation * 1  5/98 (5.10%)  6 2/24 (8.33%)  2 1/19 (5.26%)  1 1/20 (5.00%)  1 2/23 (8.70%)  2 2/22 (9.09%)  2
Vomiting * 1  0/98 (0.00%)  0 3/24 (12.50%)  5 7/19 (36.84%)  7 1/20 (5.00%)  1 5/23 (21.74%)  6 2/22 (9.09%)  2
Dry mouth * 1  6/98 (6.12%)  6 2/24 (8.33%)  2 2/19 (10.53%)  2 2/20 (10.00%)  2 2/23 (8.70%)  2 1/22 (4.55%)  1
Dyspepsia * 1  4/98 (4.08%)  4 0/24 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Abdominal pain * 1  0/98 (0.00%)  0 1/24 (4.17%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  1
Abdominal pain upper * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 3/23 (13.04%)  3 1/22 (4.55%)  1
Hypoaesthesia oral * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Diarrhoea * 1  5/98 (5.10%)  6 1/24 (4.17%)  1 0/19 (0.00%)  0 2/20 (10.00%)  2 1/23 (4.35%)  1 0/22 (0.00%)  0
General disorders             
Fatigue * 1  4/98 (4.08%)  4 2/24 (8.33%)  2 1/19 (5.26%)  1 1/20 (5.00%)  1 2/23 (8.70%)  2 1/22 (4.55%)  1
Feeling abnormal * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Product taste abnormal * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 3/23 (13.04%)  3 2/22 (9.09%)  2
Infections and infestations             
Bronchitis * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Urinary tract infection * 1  0/98 (0.00%)  0 1/24 (4.17%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Nasopharyngitis * 1  2/98 (2.04%)  2 0/24 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Injury, poisoning and procedural complications             
Poisoning * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Investigations             
Blood pressure increased * 1  0/98 (0.00%)  0 1/24 (4.17%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Blood thyroid stimulating hormone increased * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Electrocardiogram RR interval prolonged * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Weight increased * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Neck pain * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Back pain * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Muscle twitching * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 2/23 (8.70%)  2 0/22 (0.00%)  0
Nervous system disorders             
Dizziness * 1  5/98 (5.10%)  5 4/24 (16.67%)  5 9/19 (47.37%)  10 1/20 (5.00%)  1 5/23 (21.74%)  5 4/22 (18.18%)  4
Headache * 1  14/98 (14.29%)  19 1/24 (4.17%)  1 5/19 (26.32%)  8 4/20 (20.00%)  5 1/23 (4.35%)  2 5/22 (22.73%)  8
Sedation * 1  2/98 (2.04%)  2 3/24 (12.50%)  4 5/19 (26.32%)  5 0/20 (0.00%)  0 4/23 (17.39%)  5 1/22 (4.55%)  1
Dysgeusia * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 3/19 (15.79%)  3 0/20 (0.00%)  0 1/23 (4.35%)  1 2/22 (9.09%)  2
Hypoaesthesia * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Somnolence * 1  2/98 (2.04%)  2 0/24 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 2/23 (8.70%)  2 2/22 (9.09%)  3
Psychiatric disorders             
Agitation * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Anxiety * 1  1/98 (1.02%)  1 0/24 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1 1/23 (4.35%)  1 0/22 (0.00%)  0
Suicidal ideation * 1  1/98 (1.02%)  3 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Euphoric mood * 1  0/98 (0.00%)  0 2/24 (8.33%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders             
Hyperhidrosis * 1  3/98 (3.06%)  3 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 4/23 (17.39%)  4 1/22 (4.55%)  1
Night sweats * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Rash * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Urticaria * 1  0/98 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
*
Indicates events were collected by non-systematic assessment
Two subjects randomized to 8/8 received 2/2 and are presented in the Participant Flow, Baseline, and AE tables by actual treatment received. For the outcome measures, subjects were analyzed by randomization treatment assignment.
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
Phone: 781-609-7000
EMail: Eva.Stroynowski@alkermes.com
Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01500200     History of Changes
Other Study ID Numbers: ALK5461-202
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: March 1, 2019
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019