Trial Outcomes & Findings for Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia (NCT NCT02892422)
NCT ID: NCT02892422
Last Updated: 2020-10-26
Results Overview
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
528 participants
Primary outcome timeframe
From dosing to end of study (57 weeks)
Results posted on
2020-10-26
Participant Flow
Participants who had completed either study 16159A or 16323A were enrolled. Participants from study 16323A were excluded from the "all patients treated dataset" and from the "full analysis dataset".
Participant milestones
| Measure |
Lu AF35700 Flexible-dose
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
|
|---|---|
|
Overall Study
STARTED
|
528
|
|
Overall Study
COMPLETED
|
318
|
|
Overall Study
NOT COMPLETED
|
210
|
Reasons for withdrawal
| Measure |
Lu AF35700 Flexible-dose
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
|
|---|---|
|
Overall Study
Enrolled not treated
|
4
|
|
Overall Study
Adverse Event
|
38
|
|
Overall Study
Lack of Efficacy
|
32
|
|
Overall Study
Non-compliance with study drug
|
11
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
56
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
sponsor information 16159A results
|
21
|
|
Overall Study
withdrawal of consent
|
13
|
|
Overall Study
exclusion criteria met
|
3
|
|
Overall Study
moving elsewhere
|
4
|
|
Overall Study
non-compliance
|
10
|
|
Overall Study
patient legally incapable
|
1
|
|
Overall Study
patient decision
|
7
|
|
Overall Study
Investigator decision
|
1
|
Baseline Characteristics
Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Flexible-dose of Lu AF35700
n=528 Participants
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
|
|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
308 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
412 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From dosing to end of study (57 weeks)Population: Participants from study 16323A were excluded from the "all patients treated dataset" and from the "full analysis dataset".
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
Outcome measures
| Measure |
Flexible-dose of Lu AF35700
n=524 Participants
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
|
289 Participants
|
Adverse Events
Lu AF35700 Flexible-dose
Serious events: 28 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lu AF35700 Flexible-dose
n=524 participants at risk
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.38%
2/524 • Number of events 2 • 57 weeks
|
|
Nervous system disorders
Coma
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Nervous system disorders
Parkinsonism
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Acute psychosis
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Disinhibition
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Hallucination, auditory
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Insomnia
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.57%
3/524 • Number of events 3 • 57 weeks
|
|
Psychiatric disorders
Schizophrenia
|
3.1%
16/524 • Number of events 19 • 57 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.38%
2/524 • Number of events 2 • 57 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/524 • Number of events 1 • 57 weeks
|
Other adverse events
| Measure |
Lu AF35700 Flexible-dose
n=524 participants at risk
Lu AF35700: Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
|
|---|---|
|
Nervous system disorders
Headache
|
8.2%
43/524 • Number of events 49 • 57 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place