Trial Outcomes & Findings for A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study) (NCT NCT02694328)
NCT ID: NCT02694328
Last Updated: 2020-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
561 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Olanzapine
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Overall Study
STARTED
|
276
|
274
|
|
Overall Study
COMPLETED
|
176
|
176
|
|
Overall Study
NOT COMPLETED
|
100
|
98
|
Reasons for withdrawal
| Measure |
Olanzapine
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Overall Study
Adverse Event
|
27
|
33
|
|
Overall Study
Withdrawal by Subject
|
27
|
23
|
|
Overall Study
Lost to Follow-up
|
26
|
22
|
|
Overall Study
Noncompliant with study drug
|
11
|
8
|
|
Overall Study
Incarceration
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Abnormal Laboratory Value
|
0
|
3
|
Baseline Characteristics
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Baseline characteristics by cohort
| Measure |
Olanzapine
n=276 Participants
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=274 Participants
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.01 • n=99 Participants
|
40.3 years
STANDARD_DEVIATION 9.79 • n=107 Participants
|
40.2 years
STANDARD_DEVIATION 9.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
400 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
234 Participants
n=99 Participants
|
237 Participants
n=107 Participants
|
471 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
193 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
392 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
276 participants
n=99 Participants
|
274 participants
n=107 Participants
|
550 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment
Outcome measures
| Measure |
Olanzapine
n=272 Participants
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=266 Participants
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24
|
6.59 Percent change in body weight
Standard Error 0.668
|
4.21 Percent change in body weight
Standard Error 0.681
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.
Outcome measures
| Measure |
Olanzapine
n=272 Participants
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=266 Participants
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Percentage of Participants With >/= 10% Weight Gain at Week 24
|
29.8 Percentage of participants
|
17.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.
Outcome measures
| Measure |
Olanzapine
n=272 Participants
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=266 Participants
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Percentage of Participants With >/= 7% Weight Gain at Week 24
|
42.7 Percentage of participants
|
27.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The Safety Population includes all randomized subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
Olanzapine
n=276 Participants
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=274 Participants
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Number of Participants Experiencing of Adverse Events (AEs)
|
227 Participants
|
203 Participants
|
Adverse Events
Olanzapine
Serious events: 7 serious events
Other events: 159 other events
Deaths: 0 deaths
ALKS 3831
Serious events: 10 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olanzapine
n=276 participants at risk
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=274 participants at risk
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Abdominal wall abscess
|
0.36%
1/276 • Number of events 1 • Up to 24 weeks
|
0.00%
0/274 • Up to 24 weeks
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.36%
1/276 • Number of events 1 • Up to 24 weeks
|
0.00%
0/274 • Up to 24 weeks
|
|
Infections and infestations
Infectious colitis
|
0.36%
1/276 • Number of events 1 • Up to 24 weeks
|
0.00%
0/274 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/276 • Number of events 1 • Up to 24 weeks
|
0.00%
0/274 • Up to 24 weeks
|
|
Nervous system disorders
Sedation
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
0.36%
1/276 • Number of events 1 • Up to 24 weeks
|
0.00%
0/274 • Up to 24 weeks
|
|
Psychiatric disorders
Schizophrenia
|
1.1%
3/276 • Number of events 3 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/276 • Up to 24 weeks
|
0.36%
1/274 • Number of events 1 • Up to 24 weeks
|
Other adverse events
| Measure |
Olanzapine
n=276 participants at risk
Administered as a coated bilayer tablet
Olanzapine: Daily dosing
|
ALKS 3831
n=274 participants at risk
Administered as a coated bilayer tablet
ALKS 3831: Daily dosing
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
22/276 • Number of events 22 • Up to 24 weeks
|
12.8%
35/274 • Number of events 36 • Up to 24 weeks
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
6.2%
17/276 • Number of events 29 • Up to 24 weeks
|
5.1%
14/274 • Number of events 18 • Up to 24 weeks
|
|
Investigations
Weight increased
|
36.2%
100/276 • Number of events 102 • Up to 24 weeks
|
24.8%
68/274 • Number of events 68 • Up to 24 weeks
|
|
Investigations
Waist circumference increased
|
8.0%
22/276 • Number of events 22 • Up to 24 weeks
|
6.2%
17/274 • Number of events 17 • Up to 24 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
12/276 • Number of events 15 • Up to 24 weeks
|
5.1%
14/274 • Number of events 16 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
12.3%
34/276 • Number of events 35 • Up to 24 weeks
|
10.9%
30/274 • Number of events 30 • Up to 24 weeks
|
|
Nervous system disorders
Somnolence
|
18.1%
50/276 • Number of events 57 • Up to 24 weeks
|
21.2%
58/274 • Number of events 63 • Up to 24 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