Trial Outcomes & Findings for A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia (NCT NCT02873208)
NCT ID: NCT02873208
Last Updated: 2021-07-21
Results Overview
Overall summary of treatment emergent adverse events during the treatment period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
266 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2021-07-21
Participant Flow
Subjects that had completed the 24-week treatment period of the antecedent study ALK3831-A303 within seven days prior to enrollment were eligible to be enrolled in the study.
One patient was enrolled and not dosed. A total of 265 patients were administered at least one dose of ALKS 3831 and included in the safety population.
Participant milestones
| Measure |
ALKS 3831
All subjects assigned to ALKS 3831
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Overall Study
STARTED
|
265
|
|
Overall Study
COMPLETED
|
167
|
|
Overall Study
NOT COMPLETED
|
98
|
Reasons for withdrawal
| Measure |
ALKS 3831
All subjects assigned to ALKS 3831
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Non-compliance with study drug
|
12
|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Incarceration
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
ALKS 3831
n=265 Participants
All subjects assigned to ALKS 3831
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
225 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
187 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Height
|
173.24 centimeters
STANDARD_DEVIATION 8.992 • n=5 Participants
|
|
Weight
|
80.64 kilograms
STANDARD_DEVIATION 14.698 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.76 kg/m²
STANDARD_DEVIATION 3.756 • n=5 Participants
|
|
Body Mass Index (BMI) Group
Underweight (<18.5)
|
1 Participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
Normal (18.5 to <25)
|
85 Participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
Overweight (>=25 to <30)
|
121 Participants
n=5 Participants
|
|
Body Mass Index (BMI) Group
Obese (>=30)
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety population was defined as all subjects who received at least one dose of the study drug
Overall summary of treatment emergent adverse events during the treatment period
Outcome measures
| Measure |
ALKS 3831
n=265 Participants
All subjects assigned to ALKS 3831
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Number of Subjects With Adverse Events
Any Treatment Emergent Adverse Event (TEAE)
|
161 Participants
|
|
Number of Subjects With Adverse Events
Mild Treatment Emergent Adverse Event (TEAE)
|
93 Participants
|
|
Number of Subjects With Adverse Events
Moderate Treatment- Emergent Adverse Event (TEAE)
|
61 Participants
|
|
Number of Subjects With Adverse Events
Severe Treatment- Emergent Adverse Event (TEAE)
|
7 Participants
|
|
Number of Subjects With Adverse Events
Treatment- Emergent Adverse Event (TEAE)-Not Related
|
82 Participants
|
|
Number of Subjects With Adverse Events
Treatment- Emergent Adverse Event (TEAE)-Related
|
79 Participants
|
|
Number of Subjects With Adverse Events
Adverse Event Leading to Treatment Discontinuation
|
15 Participants
|
|
Number of Subjects With Adverse Events
Any Serious Adverse Event (SAE)
|
5 Participants
|
|
Number of Subjects With Adverse Events
Serious Adverse Event (SAE) -Not Related
|
4 Participants
|
|
Number of Subjects With Adverse Events
Serious Adverse Event (SAE)-Related
|
1 Participants
|
|
Number of Subjects With Adverse Events
Serious Adverse Event (SAE) leading to Death
|
0 Participants
|
Adverse Events
ALKS 3831
Serious events: 5 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALKS 3831
n=265 participants at risk
All subjects assigned to ALKS 3831 in ALKS 3831-A303 and ALKS 3831-A304
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.38%
1/265 • 52 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.75%
2/265 • 52 weeks
|
|
Psychiatric disorders
Agitation
|
0.38%
1/265 • 52 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.38%
1/265 • 52 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.38%
1/265 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/265 • 52 weeks
|
Other adverse events
| Measure |
ALKS 3831
n=265 participants at risk
All subjects assigned to ALKS 3831 in ALKS 3831-A303 and ALKS 3831-A304
ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Oral tablet, daily dosing
|
|---|---|
|
Gastrointestinal disorders
Toothache
|
2.6%
7/265 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.3%
6/265 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
12/265 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
10/265 • 52 weeks
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
7.9%
21/265 • 52 weeks
|
|
Investigations
Weight decreased
|
8.7%
23/265 • 52 weeks
|
|
Investigations
Weight increased
|
6.0%
16/265 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
3.0%
8/265 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
9/265 • 52 weeks
|
|
Nervous system disorders
Headache
|
6.8%
18/265 • 52 weeks
|
|
Vascular disorders
Hypertension
|
2.3%
6/265 • 52 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