Trial Outcomes & Findings for A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment. (NCT NCT02281773)
NCT ID: NCT02281773
Last Updated: 2017-10-19
Results Overview
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.
COMPLETED
PHASE2
518 participants
Baseline and Week 12
2017-10-19
Participant Flow
A phase II multi-centre, multi-national, randomised, double-blind, placebo-controlled parallel group trial to evaluate the efficacy, safety and tolerability of four orally administrated doses of BI 409306 during a 12-week treatment period in patients with schizophrenia on stable antipsychotic treatment.
Actually, 518 subjects were entered/randomised however 2 subjects were not treated and hence the number of subjects that started equals 516. One belongs to BI 409306 - 25 milligram and another to Placebo group.
Participant milestones
| Measure |
BI 409306 - 10 Milligram
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
85
|
85
|
86
|
173
|
|
Overall Study
COMPLETED
|
76
|
70
|
67
|
65
|
143
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
18
|
21
|
30
|
Reasons for withdrawal
| Measure |
BI 409306 - 10 Milligram
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
4
|
8
|
9
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
6
|
2
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
6
|
6
|
8
|
|
Overall Study
Other Reason
|
0
|
4
|
2
|
3
|
1
|
Baseline Characteristics
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
Baseline characteristics by cohort
| Measure |
BI 409306 - 10 Milligram
n=87 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
Total
n=516 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
41.4 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
42.3 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
41.5 Years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
42.3 Years
STANDARD_DEVIATION 9.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
156 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
360 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=79 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=76 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=69 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=76 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=150 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment
|
1.2 Unit on Scale
Standard Error 0.71
|
2.7 Unit on Scale
Standard Error 0.74
|
2.8 Unit on Scale
Standard Error 0.75
|
1.8 Unit on Scale
Standard Error 0.73
|
2.5 Unit on Scale
Standard Error 0.57
|
PRIMARY outcome
Timeframe: Up to 20 weeksPopulation: The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.
Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=87 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 20 weeksPopulation: The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.
Occurrence of Protocol-specified adverse events of special interest (AESI).
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=87 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6 and Week 12Population: TS
Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=87 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)
W6-Number of participants analyzed:79,74,67,71,154
|
-0.68 Unit on Scale
Standard Deviation 6.022
|
-0.28 Unit on Scale
Standard Deviation 4.507
|
-1.09 Unit on Scale
Standard Deviation 5.415
|
-1.20 Unit on Scale
Standard Deviation 5.426
|
-1.81 Unit on Scale
Standard Deviation 5.895
|
|
Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)
W12-Number of participant analyzed:83,78,76,81,157
|
-2.59 Unit on Scale
Standard Deviation 5.342
|
-0.97 Unit on Scale
Standard Deviation 5.420
|
-1.58 Unit on Scale
Standard Deviation 6.990
|
-0.94 Unit on Scale
Standard Deviation 6.315
|
-1.66 Unit on Scale
Standard Deviation 6.942
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: TS (Number of subjects with a post baseline C-SSRS)
C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=84 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=84 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=79 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=85 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=166 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)
|
0.0 Percentage of Participants
3.677
|
1.2 Percentage of Participants
3.262
|
2.5 Percentage of Participants
3.759
|
1.2 Percentage of Participants
3.497
|
3.6 Percentage of Participants
3.954
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.
Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If \>5 items were missing, the total score was missing.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=82 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=75 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=73 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=80 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=156 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment
|
-2.2 Unit on Scale
Standard Error 0.53
|
-3.1 Unit on Scale
Standard Error 0.56
|
-2.0 Unit on Scale
Standard Error 0.56
|
-2.3 Unit on Scale
Standard Error 0.54
|
-2.5 Unit on Scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=82 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=77 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=73 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=81 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=157 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment
|
-0.1 Unit on Scale
Standard Error 0.05
|
-0.1 Unit on Scale
Standard Error 0.05
|
-0.1 Unit on Scale
Standard Error 0.05
|
-0.1 Unit on Scale
Standard Error 0.05
|
-0.1 Unit on Scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: FAS
Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient's overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=82 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=77 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=73 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=82 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=157 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment
|
2.988 Unit on Scale
Standard Deviation 1.117
|
2.883 Unit on Scale
Standard Deviation 1.124
|
3.192 Unit on Scale
Standard Deviation 1.101
|
3.049 Unit on Scale
Standard Deviation 1.342
|
3.038 Unit on Scale
Standard Deviation 1.109
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: This endpoint was not analysed because as per internal Boehringer Ingelheim rules, descriptive statistics are not calculated if data is available for less than 2/3rds of participants.
Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 12Population: TS
Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Outcome measures
| Measure |
BI 409306 - 10 Milligram
n=87 Participants
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 Participants
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 Participants
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 Participants
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 Participants
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
W6-Number of participants analyzed:79,74,67,71,154
|
-0.39 Unit on Scale
Standard Deviation 3.677
|
-0.22 Unit on Scale
Standard Deviation 3.262
|
-0.31 Unit on Scale
Standard Deviation 3.759
|
-0.79 Unit on Scale
Standard Deviation 3.497
|
-0.99 Unit on Scale
Standard Deviation 3.954
|
|
Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
W12-Number of participant analyzed:83,78,76,81,157
|
-1.36 Unit on Scale
Standard Deviation 3.039
|
-0.79 Unit on Scale
Standard Deviation 3.277
|
-0.68 Unit on Scale
Standard Deviation 4.253
|
-0.38 Unit on Scale
Standard Deviation 3.587
|
-0.76 Unit on Scale
Standard Deviation 4.007
|
Adverse Events
BI 409306 - 10 Milligram
BI 409306 - 25 Milligram
BI 409306 - 50 Milligram
BI 409306 - 100 Milligram
Placebo
Serious adverse events
| Measure |
BI 409306 - 10 Milligram
n=87 participants at risk
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 participants at risk
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 participants at risk
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 participants at risk
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 participants at risk
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.58%
1/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.58%
1/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Infections and infestations
Empyema
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.58%
1/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.58%
1/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
2.9%
5/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
1.7%
3/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.58%
1/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
Other adverse events
| Measure |
BI 409306 - 10 Milligram
n=87 participants at risk
Subject received single oral dose of 10 milligram (mg) BI 409306 (film-coated tablet) along with two placebo matching 25mg/50mg tablets once daily for 12 weeks.
|
BI 409306 - 25 Milligram
n=85 participants at risk
Subject received single oral dose of 25 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 50 Milligram
n=85 participants at risk
Subject received single oral dose of 50 milligram (mg) BI 409306 (film-coated tablet) along with placebo matching 10mg and 25mg/50mg tablet once daily for 12 weeks.
|
BI 409306 - 100 Milligram
n=86 participants at risk
Subject received single oral dose of 100 milligram (mg) BI 409306 (2 film-coated tablets of 50 mg) along with placebo matching 10mg tablet once daily for 12 weeks.
|
Placebo
n=173 participants at risk
Subject received single oral dose of placebo matching tablets (one placebo matching 10mg tablet and two placebo matching 25mg/50mg tablets) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
2.4%
2/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
2.4%
2/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
7.0%
6/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
1.2%
2/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Eye disorders
Visual brightness
|
0.00%
0/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
2.4%
2/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
3.5%
3/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
7.0%
6/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
0.00%
0/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
|
Nervous system disorders
Headache
|
5.7%
5/87 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
5.9%
5/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
4.7%
4/85 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
1.2%
1/86 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
5.8%
10/173 • From first drug administration until 4 weeks after the last drug administration, up to 16 weeks
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER