Trial Outcomes & Findings for A Long-Term Safety Study of ALKS 5461 (NCT NCT02141399)
NCT ID: NCT02141399
Last Updated: 2018-12-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1485 participants
Primary outcome timeframe
Up to 56 weeks
Results posted on
2018-12-14
Participant Flow
Subjects were entered into the study in one of 3 ways, based upon previous experience with a prior ALKS 5461 study: Subjects continuing from a prior ALKS 5461 study; Subjects who participated in the prospective lead-in for a prior ALKS 5461 study, but did not meet the entrance criteria; Subjects who did not participate in a prior ALKS 5461 study.
All subjects received ALKS 5461 during the course of the study as an adjunctive treatment for major depressive disorder. In addition all subjects were treated with background antidepressant therapy prescribed by the investigator.
Participant milestones
| Measure |
ALKS 5461
ALKS 5461 adjunctive treatment
|
|---|---|
|
Overall Study
STARTED
|
1485
|
|
Overall Study
COMPLETED
|
741
|
|
Overall Study
NOT COMPLETED
|
744
|
Reasons for withdrawal
| Measure |
ALKS 5461
ALKS 5461 adjunctive treatment
|
|---|---|
|
Overall Study
Adverse Event
|
158
|
|
Overall Study
Lack of Efficacy
|
62
|
|
Overall Study
Lost to Follow-up
|
151
|
|
Overall Study
Non-compliance with study drug
|
18
|
|
Overall Study
Other
|
45
|
|
Overall Study
Physician Decision
|
17
|
|
Overall Study
Pregnancy
|
3
|
|
Overall Study
Protocol Violation
|
38
|
|
Overall Study
Withdrawal by Subject
|
238
|
|
Overall Study
Failure to meet eligibility criteria
|
14
|
Baseline Characteristics
A Long-Term Safety Study of ALKS 5461
Baseline characteristics by cohort
| Measure |
ALKS 5461
n=1485 Participants
ALKS 5461 adjunctive treatment
|
|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
964 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
521 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1288 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
362 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1080 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1204 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 56 weeksPopulation: The safety population included all subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
ALKS 5461
n=1485 Participants
ALKS 5461 adjunctive treatment
|
|---|---|
|
Incidence of Adverse Events (AEs)
|
1124 Participants
|
Adverse Events
ALKS 5461
Serious events: 47 serious events
Other events: 1124 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
ALKS 5461
n=1485 participants at risk
ALKS 5461 adjunctive treatment
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Infections and infestations
Sepsis
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Psychiatric disorders
Depression
|
0.20%
3/1485 • Number of events 3 • Up to 56 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.20%
3/1485 • Number of events 3 • Up to 56 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
General disorders
Asthenia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
General disorders
Chest pain
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
General disorders
Pyrexia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Cellulitis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Meningitis viral
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Otitis media
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Psychiatric disorders
Major depression
|
0.13%
2/1485 • Number of events 2 • Up to 56 weeks
|
|
Psychiatric disorders
Conversion disorder
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Reproductive system and breast disorders
Endometriosis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
|
Vascular disorders
Phlebitis
|
0.07%
1/1485 • Number of events 1 • Up to 56 weeks
|
Other adverse events
| Measure |
ALKS 5461
n=1485 participants at risk
ALKS 5461 adjunctive treatment
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
21.7%
322/1485 • Number of events 409 • Up to 56 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.2%
151/1485 • Number of events 173 • Up to 56 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
116/1485 • Number of events 134 • Up to 56 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
87/1485 • Number of events 95 • Up to 56 weeks
|
|
Nervous system disorders
Headache
|
10.5%
156/1485 • Number of events 198 • Up to 56 weeks
|
|
Nervous system disorders
Dizziness
|
10.1%
150/1485 • Number of events 179 • Up to 56 weeks
|
|
Nervous system disorders
Somnolence
|
8.4%
124/1485 • Number of events 142 • Up to 56 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
83/1485 • Number of events 98 • Up to 56 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
80/1485 • Number of events 88 • Up to 56 weeks
|
|
Psychiatric disorders
Insomnia
|
5.5%
81/1485 • Number of events 90 • Up to 56 weeks
|
|
General disorders
Fatigue
|
5.7%
85/1485 • Number of events 91 • Up to 56 weeks
|
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