Trial Outcomes & Findings for A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms (NCT NCT03669640)
NCT ID: NCT03669640
Last Updated: 2024-08-12
Results Overview
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78. The avolition/apathy subscale contains 2 items with a total score range of 0-12.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
Part A: Monotherapy (Placebo)
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
37
|
5
|
30
|
32
|
|
Overall Study
COMPLETED
|
10
|
7
|
33
|
5
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Part A: Monotherapy (Placebo)
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Relapse
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Baseline characteristics by cohort
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
41.3 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
41.6 Years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
40.0 Years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
40.9 Years
STANDARD_DEVIATION 9.2 • n=10 Participants
|
41.3 Years
STANDARD_DEVIATION 9.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
92 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
116 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
55 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78. The avolition/apathy subscale contains 2 items with a total score range of 0-12.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
Week 12 (Day 84) Avolition/Apathy Subscore
|
5.50 Units on a scale
Standard Deviation 2.55
|
4.67 Units on a scale
Standard Deviation 3.27
|
5.0 Units on a scale
Standard Deviation 1.9
|
5.3 Units on a scale
Standard Deviation 1.0
|
4.1 Units on a scale
Standard Deviation 2.1
|
4.7 Units on a scale
Standard Deviation 2.1
|
|
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
Baseline Avolition/Apathy Subscore
|
5.71 Units on a scale
Standard Deviation 2.81
|
5.50 Units on a scale
Standard Deviation 2.71
|
6.0 Units on a scale
Standard Deviation 2.3
|
6.2 Units on a scale
Standard Deviation 1.3
|
5.8 Units on a scale
Standard Deviation 1.9
|
5.9 Units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug. Data for this endpoint was not collected for Part B on Day 70.
The CGI-S is an absolute measure assessing how mentally ill the participant is at the time of the assessment on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). On the scale, the value 0 corresponds to 'not assessed', which will be excluded from the analyses. The values 1 to 7 will be transformed into the 0 to 6 range prior to statistical analysis for the question on the measure ("Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?"), making the total score range 0-6.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Baseline
|
3.600 Units on a scale
Standard Deviation 0.507
|
3.667 Units on a scale
Standard Deviation 0.492
|
4.1 Units on a scale
Standard Deviation 0.7
|
3.8 Units on a scale
Standard Deviation 0.4
|
3.9 Units on a scale
Standard Deviation 0.7
|
4.0 Units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 14
|
3.467 Units on a scale
Standard Deviation 0.516
|
3.700 Units on a scale
Standard Deviation 0.483
|
4.0 Units on a scale
Standard Deviation 0.6
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.8 Units on a scale
Standard Deviation 0.6
|
4.0 Units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 28
|
3.500 Units on a scale
Standard Deviation 0.527
|
3.333 Units on a scale
Standard Deviation 0.500
|
3.9 Units on a scale
Standard Deviation 0.8
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.8 Units on a scale
Standard Deviation 0.6
|
3.7 Units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 42
|
3.636 Units on a scale
Standard Deviation 0.809
|
3.375 Units on a scale
Standard Deviation 0.744
|
3.8 Units on a scale
Standard Deviation 0.8
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.6 Units on a scale
Standard Deviation 0.6
|
3.6 Units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 56
|
3.636 Units on a scale
Standard Deviation 0.505
|
3.143 Units on a scale
Standard Deviation 0.378
|
3.8 Units on a scale
Standard Deviation 0.8
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.5 Units on a scale
Standard Deviation 0.7
|
3.5 Units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 70
|
3.500 Units on a scale
Standard Deviation 0.707
|
3.143 Units on a scale
Standard Deviation 0.690
|
—
|
—
|
—
|
—
|
|
Clinical Global Impression Severity (CGI-S) Overall Scores
Day 84
|
3.700 Units on a scale
Standard Deviation 0.483
|
3.000 Units on a scale
Standard Deviation 0.632
|
3.7 Units on a scale
Standard Deviation 0.8
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.4 Units on a scale
Standard Deviation 0.6
|
3.5 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug. Data for this endpoint was not collected for Part B on Day 70.
The CGI-S-NS is similar to the CGI-S and is assessed on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). On the scale, the value 0 corresponds to 'not assessed', which will be excluded from the analyses. The values 1 to 7 will be transformed into the 0 to 6 range prior to statistical analysis for the question on the measure, making the total score range 0-6.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
CGI-S Negative Symptoms (NS) Scores
Baseline
|
3.867 Units on a scale
Standard Deviation 0.743
|
3.917 Units on a scale
Standard Deviation 0.669
|
4.4 Units on a scale
Standard Deviation 0.6
|
4.2 Units on a scale
Standard Deviation 0.4
|
4.3 Units on a scale
Standard Deviation 0.7
|
4.3 Units on a scale
Standard Deviation 0.7
|
|
CGI-S Negative Symptoms (NS) Scores
Day 14
|
3.600 Units on a scale
Standard Deviation 0.632
|
3.800 Units on a scale
Standard Deviation 0.632
|
4.3 Units on a scale
Standard Deviation 0.7
|
4.3 Units on a scale
Standard Deviation 0.5
|
3.9 Units on a scale
Standard Deviation 0.7
|
4.1 Units on a scale
Standard Deviation 0.7
|
|
CGI-S Negative Symptoms (NS) Scores
Day 28
|
3.800 Units on a scale
Standard Deviation 0.632
|
3.778 Units on a scale
Standard Deviation 0.667
|
4.1 Units on a scale
Standard Deviation 0.8
|
4.3 Units on a scale
Standard Deviation 0.5
|
3.8 Units on a scale
Standard Deviation 0.7
|
3.9 Units on a scale
Standard Deviation 0.7
|
|
CGI-S Negative Symptoms (NS) Scores
Day 42
|
3.727 Units on a scale
Standard Deviation 0.467
|
3.625 Units on a scale
Standard Deviation 0.518
|
3.9 Units on a scale
Standard Deviation 0.9
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.8 Units on a scale
Standard Deviation 0.7
|
3.7 Units on a scale
Standard Deviation 0.7
|
|
CGI-S Negative Symptoms (NS) Scores
Day 56
|
3.636 Units on a scale
Standard Deviation 0.674
|
3.714 Units on a scale
Standard Deviation 0.756
|
3.9 Units on a scale
Standard Deviation 0.8
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.6 Units on a scale
Standard Deviation 0.7
|
3.5 Units on a scale
Standard Deviation 0.7
|
|
CGI-S Negative Symptoms (NS) Scores
Day 70
|
3.500 Units on a scale
Standard Deviation 0.527
|
3.286 Units on a scale
Standard Deviation 0.756
|
—
|
—
|
—
|
—
|
|
CGI-S Negative Symptoms (NS) Scores
Day 84
|
3.400 Units on a scale
Standard Deviation 0.516
|
3.167 Units on a scale
Standard Deviation 0.753
|
3.9 Units on a scale
Standard Deviation 0.8
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.4 Units on a scale
Standard Deviation 0.6
|
3.5 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to Week 12 (Day 84)Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug. Data for this endpoint was not collected for Part B Days 21, 35, and 70.
The CGI-I assesses how much the participant's condition has changed at the time of the assessment in comparison to their condition at baseline. It uses a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where the value 0 corresponds to 'not assessed' and will be excluded from any analyses.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 14
|
3.71 Units on a scale
Standard Deviation 0.91
|
3.56 Units on a scale
Standard Deviation 0.53
|
3.7 Units on a scale
Standard Deviation 0.4
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.6 Units on a scale
Standard Deviation 0.5
|
3.6 Units on a scale
Standard Deviation 0.6
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 21
|
4.00 Units on a scale
Standard Deviation NA
SD cannot be calculated with a single value
|
2.00 Units on a scale
Standard Deviation NA
SD cannot be calculated with a single value
|
—
|
—
|
—
|
—
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 28
|
3.56 Units on a scale
Standard Deviation 0.73
|
3.50 Units on a scale
Standard Deviation 0.76
|
3.5 Units on a scale
Standard Deviation 0.7
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.5 Units on a scale
Standard Deviation 0.8
|
3.4 Units on a scale
Standard Deviation 0.8
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 35
|
3.50 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 42
|
3.73 Units on a scale
Standard Deviation 0.65
|
3.29 Units on a scale
Standard Deviation 0.76
|
3.4 Units on a scale
Standard Deviation 0.7
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.3 Units on a scale
Standard Deviation 0.8
|
3.3 Units on a scale
Standard Deviation 0.9
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 56
|
3.70 Units on a scale
Standard Deviation 0.48
|
3.14 Units on a scale
Standard Deviation 0.69
|
3.4 Units on a scale
Standard Deviation 0.7
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.4 Units on a scale
Standard Deviation 0.9
|
3.1 Units on a scale
Standard Deviation 1.0
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 70
|
3.50 Units on a scale
Standard Deviation 0.71
|
2.86 Units on a scale
Standard Deviation 0.90
|
—
|
—
|
—
|
—
|
|
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Day 84
|
3.80 Units on a scale
Standard Deviation 0.42
|
3.00 Units on a scale
Standard Deviation 0.63
|
3.2 Units on a scale
Standard Deviation 0.7
|
3.8 Units on a scale
Standard Deviation 0.5
|
3.0 Units on a scale
Standard Deviation 0.9
|
3.0 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to Week 12 (Day 84)Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The CGI-I NS is similar to the CGI-I and assesses how much the participant's condition has changed at the time of the assessment in comparison to their condition at baseline. It uses a 7-point scale, where: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
CGI-I Negative Symptoms Scores
Day 84
|
3.10 Units on a scale
Standard Deviation 0.74
|
2.83 Units on a scale
Standard Deviation 0.41
|
3.1 Units on a scale
Standard Deviation 0.7
|
3.0 Units on a scale
Standard Deviation 0.8
|
2.9 Units on a scale
Standard Deviation 0.9
|
2.8 Units on a scale
Standard Deviation 0.9
|
|
CGI-I Negative Symptoms Scores
Day 14
|
3.71 Units on a scale
Standard Deviation 0.61
|
3.44 Units on a scale
Standard Deviation 0.73
|
3.7 Units on a scale
Standard Deviation 0.5
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.5 Units on a scale
Standard Deviation 0.6
|
3.5 Units on a scale
Standard Deviation 0.6
|
|
CGI-I Negative Symptoms Scores
Day 21
|
5.00 Units on a scale
Standard Deviation NA
SD cannot be calculated with a single value
|
4.00 Units on a scale
Standard Deviation NA
SD cannot be calculated with a single value
|
—
|
—
|
—
|
—
|
|
CGI-I Negative Symptoms Scores
Day 28
|
3.44 Units on a scale
Standard Deviation 0.73
|
3.38 Units on a scale
Standard Deviation 0.74
|
3.5 Units on a scale
Standard Deviation 0.7
|
4.0 Units on a scale
Standard Deviation 0.0
|
3.3 Units on a scale
Standard Deviation 0.7
|
3.2 Units on a scale
Standard Deviation 0.8
|
|
CGI-I Negative Symptoms Scores
Day 35
|
4.50 Units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
|
CGI-I Negative Symptoms Scores
Day 42
|
3.45 Units on a scale
Standard Deviation 0.69
|
3.43 Units on a scale
Standard Deviation 0.79
|
3.3 Units on a scale
Standard Deviation 0.6
|
3.5 Units on a scale
Standard Deviation 0.6
|
3.3 Units on a scale
Standard Deviation 0.8
|
3.2 Units on a scale
Standard Deviation 0.8
|
|
CGI-I Negative Symptoms Scores
Day 56
|
3.50 Units on a scale
Standard Deviation 0.71
|
3.43 Units on a scale
Standard Deviation 0.53
|
3.2 Units on a scale
Standard Deviation 0.7
|
3.5 Units on a scale
Standard Deviation 0.6
|
3.2 Units on a scale
Standard Deviation 0.8
|
2.9 Units on a scale
Standard Deviation 0.8
|
|
CGI-I Negative Symptoms Scores
Day 70
|
3.40 Units on a scale
Standard Deviation 0.70
|
3.00 Units on a scale
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The PANSS Marder factors examine schizophrenia symptoms in five domains: positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and depression/anxiety. The Marder factor positive symptom score (range = 8-56) measures responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12) while the negative symptom factor score (range = 7-49) consists of 7 items (N1,N2,N3,N4,N6,G7,G16). Each item is scored on a scale of 1-7, where 1 = an absence of symptoms and 7 = extreme symptoms. The positive and negative syndrome scale total score is the sum of the scores from each domain (range = 15-105); higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Baseline
|
67.43 Units on a scale
Standard Deviation 9.35
|
67.92 Units on a scale
Standard Deviation 10.86
|
71.4 Units on a scale
Standard Deviation 10.3
|
62.8 Units on a scale
Standard Deviation 6.7
|
69.6 Units on a scale
Standard Deviation 11.1
|
67.8 Units on a scale
Standard Deviation 11.1
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 14
|
68.38 Units on a scale
Standard Deviation 10.37
|
69.00 Units on a scale
Standard Deviation 11.40
|
67.3 Units on a scale
Standard Deviation 8.5
|
69.5 Units on a scale
Standard Deviation 13.5
|
67.4 Units on a scale
Standard Deviation 10.5
|
67.9 Units on a scale
Standard Deviation 13.6
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 28
|
66.10 Units on a scale
Standard Deviation 10.38
|
65.44 Units on a scale
Standard Deviation 7.30
|
67.0 Units on a scale
Standard Deviation 10.9
|
81.3 Units on a scale
Standard Deviation 4.7
|
66.8 Units on a scale
Standard Deviation 11.4
|
66.5 Units on a scale
Standard Deviation 11.1
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 42
|
70.09 Units on a scale
Standard Deviation 10.88
|
65.88 Units on a scale
Standard Deviation 12.01
|
68.3 Units on a scale
Standard Deviation 12.7
|
73.3 Units on a scale
Standard Deviation 9.8
|
61.8 Units on a scale
Standard Deviation 10.9
|
64.1 Units on a scale
Standard Deviation 12.5
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 56
|
66.60 Units on a scale
Standard Deviation 8.13
|
61.14 Units on a scale
Standard Deviation 6.91
|
64.3 Units on a scale
Standard Deviation 11.7
|
70.0 Units on a scale
Standard Deviation 7.1
|
63.2 Units on a scale
Standard Deviation 14.4
|
61.4 Units on a scale
Standard Deviation 11.7
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 70
|
68.50 Units on a scale
Standard Deviation 7.65
|
59.57 Units on a scale
Standard Deviation 7.14
|
—
|
—
|
—
|
—
|
|
Positive and Negative Syndrome Scale (PANSS) Total Scores
Day 84 (Week 12)
|
64.70 Units on a scale
Standard Deviation 13.92
|
59.17 Units on a scale
Standard Deviation 6.27
|
64.4 Units on a scale
Standard Deviation 12.2
|
74.8 Units on a scale
Standard Deviation 7.2
|
59.0 Units on a scale
Standard Deviation 11.1
|
60.9 Units on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The PANSS Marder factors examine schizophrenia symptoms in five domains: positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and depression/anxiety. The Marder factor positive symptom score (range = 8-56) measures responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12) while the negative symptom factor score (range = 7-49) consists of 7 items (N1,N2,N3,N4,N6,G7,G16). Each item is scored on a scale of 1-7, where 1 = an absence of symptoms and 7 = extreme symptoms.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
PANSS Symptom Factor Scores
Baseline - Negative symptoms
|
21.29 Units on a scale
Standard Deviation 4.45
|
21.00 Units on a scale
Standard Deviation 5.20
|
23.0 Units on a scale
Standard Deviation 4.7
|
20.6 Units on a scale
Standard Deviation 3.3
|
23.3 Units on a scale
Standard Deviation 4.7
|
23.5 Units on a scale
Standard Deviation 4.1
|
|
PANSS Symptom Factor Scores
Day 14 - Negative symptoms
|
22.46 Units on a scale
Standard Deviation 5.13
|
20.40 Units on a scale
Standard Deviation 3.95
|
22.9 Units on a scale
Standard Deviation 3.4
|
20.8 Units on a scale
Standard Deviation 2.9
|
21.8 Units on a scale
Standard Deviation 4.5
|
22.2 Units on a scale
Standard Deviation 5.3
|
|
PANSS Symptom Factor Scores
Day 28 - Negative symptoms
|
18.40 Units on a scale
Standard Deviation 6.67
|
20.44 Units on a scale
Standard Deviation 3.68
|
20.9 Units on a scale
Standard Deviation 4.8
|
20.3 Units on a scale
Standard Deviation 3.1
|
21.5 Units on a scale
Standard Deviation 4.0
|
22.1 Units on a scale
Standard Deviation 4.9
|
|
PANSS Symptom Factor Scores
Day 42 - Negative symptoms
|
21.09 Units on a scale
Standard Deviation 5.45
|
19.00 Units on a scale
Standard Deviation 5.50
|
21.3 Units on a scale
Standard Deviation 4.5
|
22.3 Units on a scale
Standard Deviation 3.2
|
21.5 Units on a scale
Standard Deviation 5.1
|
20.7 Units on a scale
Standard Deviation 5.1
|
|
PANSS Symptom Factor Scores
Day 56 - Negative symptoms
|
21.10 Units on a scale
Standard Deviation 5.93
|
18.71 Units on a scale
Standard Deviation 4.72
|
20.4 Units on a scale
Standard Deviation 4.7
|
21.8 Units on a scale
Standard Deviation 4.2
|
19.8 Units on a scale
Standard Deviation 4.9
|
20.3 Units on a scale
Standard Deviation 5.7
|
|
PANSS Symptom Factor Scores
Day 70 - Negative symptoms
|
21.20 Units on a scale
Standard Deviation 5.07
|
17.71 Units on a scale
Standard Deviation 2.75
|
—
|
—
|
—
|
—
|
|
PANSS Symptom Factor Scores
Day 84 (Week 12) - Negative symptoms
|
18.90 Units on a scale
Standard Deviation 5.38
|
15.33 Units on a scale
Standard Deviation 3.08
|
20.5 Units on a scale
Standard Deviation 5.9
|
22.5 Units on a scale
Standard Deviation 4.8
|
18.6 Units on a scale
Standard Deviation 4.4
|
19.4 Units on a scale
Standard Deviation 4.8
|
|
PANSS Symptom Factor Scores
Baseline - Positive symptoms
|
17.93 Units on a scale
Standard Deviation 3.99
|
19.75 Units on a scale
Standard Deviation 3.93
|
18.9 Units on a scale
Standard Deviation 4.6
|
18.0 Units on a scale
Standard Deviation 3.7
|
17.6 Units on a scale
Standard Deviation 4.2
|
17.2 Units on a scale
Standard Deviation 5.4
|
|
PANSS Symptom Factor Scores
Day 14 - Positive symptoms
|
18.23 Units on a scale
Standard Deviation 4.75
|
21.30 Units on a scale
Standard Deviation 4.35
|
17.8 Units on a scale
Standard Deviation 3.8
|
18.3 Units on a scale
Standard Deviation 5.3
|
18.1 Units on a scale
Standard Deviation 3.9
|
18.0 Units on a scale
Standard Deviation 5.7
|
|
PANSS Symptom Factor Scores
Day 28 - Positive symptoms
|
17.60 Units on a scale
Standard Deviation 4.77
|
19.22 Units on a scale
Standard Deviation 5.19
|
17.9 Units on a scale
Standard Deviation 4.3
|
24.3 Units on a scale
Standard Deviation 6.0
|
18.0 Units on a scale
Standard Deviation 4.9
|
17.4 Units on a scale
Standard Deviation 5.9
|
|
PANSS Symptom Factor Scores
Day 42 - Positive symptoms
|
17.82 Units on a scale
Standard Deviation 4.31
|
18.75 Units on a scale
Standard Deviation 4.13
|
18.2 Units on a scale
Standard Deviation 4.8
|
22.5 Units on a scale
Standard Deviation 6.0
|
16.0 Units on a scale
Standard Deviation 4.4
|
16.2 Units on a scale
Standard Deviation 4.7
|
|
PANSS Symptom Factor Scores
Day 56 - Positive symptoms
|
17.90 Units on a scale
Standard Deviation 4.93
|
20.71 Units on a scale
Standard Deviation 1.50
|
17.7 Units on a scale
Standard Deviation 5.0
|
20.5 Units on a scale
Standard Deviation 3.1
|
17.2 Units on a scale
Standard Deviation 6.1
|
15.8 Units on a scale
Standard Deviation 4.5
|
|
PANSS Symptom Factor Scores
Day 70 - Positive symptoms
|
19.20 Units on a scale
Standard Deviation 2.86
|
19.29 Units on a scale
Standard Deviation 2.69
|
—
|
—
|
—
|
—
|
|
PANSS Symptom Factor Scores
Day 84 (Week 12) - Positive symptoms
|
17.70 Units on a scale
Standard Deviation 5.25
|
19.67 Units on a scale
Standard Deviation 3.61
|
17.3 Units on a scale
Standard Deviation 4.5
|
21.5 Units on a scale
Standard Deviation 2.6
|
16.5 Units on a scale
Standard Deviation 4.7
|
15.5 Units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Baseline
|
34.79 Units on a scale
Standard Deviation 14.98
|
35.17 Units on a scale
Standard Deviation 13.68
|
36.6 Units on a scale
Standard Deviation 14.9
|
36.4 Units on a scale
Standard Deviation 6.7
|
38.1 Units on a scale
Standard Deviation 13.7
|
38.4 Units on a scale
Standard Deviation 13.8
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 14
|
35.08 Units on a scale
Standard Deviation 12.48
|
32.90 Units on a scale
Standard Deviation 13.47
|
36.1 Units on a scale
Standard Deviation 11.4
|
29.3 Units on a scale
Standard Deviation 11.1
|
34.1 Units on a scale
Standard Deviation 12.8
|
35.2 Units on a scale
Standard Deviation 12.8
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 28
|
29.90 Units on a scale
Standard Deviation 14.49
|
33.25 Units on a scale
Standard Deviation 8.94
|
32.6 Units on a scale
Standard Deviation 12.9
|
32.7 Units on a scale
Standard Deviation 7.4
|
33.1 Units on a scale
Standard Deviation 13.4
|
36.5 Units on a scale
Standard Deviation 10.3
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 42
|
34.09 Units on a scale
Standard Deviation 11.95
|
36.38 Units on a scale
Standard Deviation 14.79
|
35.1 Units on a scale
Standard Deviation 11.3
|
35.0 Units on a scale
Standard Deviation 11.8
|
35.5 Units on a scale
Standard Deviation 12.6
|
32.7 Units on a scale
Standard Deviation 13.4
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 56
|
37.40 Units on a scale
Standard Deviation 18.60
|
34.00 Units on a scale
Standard Deviation 12.12
|
30.3 Units on a scale
Standard Deviation 12.1
|
37.5 Units on a scale
Standard Deviation 16.3
|
30.8 Units on a scale
Standard Deviation 11.8
|
32.3 Units on a scale
Standard Deviation 13.6
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 70
|
33.10 Units on a scale
Standard Deviation 7.23
|
34.00 Units on a scale
Standard Deviation 15.15
|
—
|
—
|
—
|
—
|
|
Brief Negative Symptom Scale (BNSS) Total Scores
Day 84 (Week 12)
|
30.40 Units on a scale
Standard Deviation 12.86
|
28.17 Units on a scale
Standard Deviation 20.44
|
32.7 Units on a scale
Standard Deviation 13.4
|
33.3 Units on a scale
Standard Deviation 10.6
|
29.6 Units on a scale
Standard Deviation 9.2
|
29.2 Units on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug.
The DPAS is a 15-item, patient-rated assessment that evaluates expectations of failures or self-defeating beliefs related to prior failed experiences as well as illness on a 7-point Likert scale (total range = 15-105) ranging from totally agree (1) to totally disagree (7).
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Defeatist Performance Attitude Scale (DPAS) Scores
Day 42
|
40.54 Units on a scale
Standard Deviation 16.37
|
27.50 Units on a scale
Standard Deviation 18.65
|
37.5 Units on a scale
Standard Deviation 14.2
|
39.3 Units on a scale
Standard Deviation 9.3
|
38.8 Units on a scale
Standard Deviation 16.2
|
36.0 Units on a scale
Standard Deviation 16.2
|
|
Defeatist Performance Attitude Scale (DPAS) Scores
Baseline
|
34.73 Units on a scale
Standard Deviation 13.92
|
30.25 Units on a scale
Standard Deviation 12.43
|
40.2 Units on a scale
Standard Deviation 14.6
|
40.0 Units on a scale
Standard Deviation 6.4
|
38.2 Units on a scale
Standard Deviation 15.9
|
35.9 Units on a scale
Standard Deviation 16.2
|
|
Defeatist Performance Attitude Scale (DPAS) Scores
Day 84 (Week 12)
|
38.80 Units on a scale
Standard Deviation 13.42
|
16.00 Units on a scale
Standard Deviation 4.98
|
36.0 Units on a scale
Standard Deviation 15.2
|
54.3 Units on a scale
Standard Deviation 16.4
|
39.0 Units on a scale
Standard Deviation 19.9
|
32.2 Units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline through Day 84Population: The safety population included all randomized participants who received at least one dose of study drug.
The C-SSRS is a suicide risk assessment tool used to help identify the risk of suicide.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior, and Self-injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation or behavior
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
|
Number of Participants With Suicidal Ideation or Behavior, and Self-injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS)
Self-injurious behavior without suicidal intent
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Baseline through Day 84Population: The safety population included all randomized participants who received at least one dose of study drug.
The ESRS-A is used to evaluate the presence and severity of extrapyramidal symptoms. Items are rated on a scale of 0 (no symptoms) to 5 (extreme symptoms).
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=15 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 Participants
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 Participants
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 Participants
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Dystonia Day 84
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.26 Units on a scale
Standard Deviation 1.03
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.05 Units on a scale
Standard Deviation 0.22
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Akathisia Baseline
|
0.07 Units on a scale
Standard Deviation 0.26
|
0.08 Units on a scale
Standard Deviation 0.29
|
0.27 Units on a scale
Standard Deviation 0.87
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.27 Units on a scale
Standard Deviation 0.83
|
0.38 Units on a scale
Standard Deviation 0.98
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Akathisia Day 84
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.29 Units on a scale
Standard Deviation 0.94
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.10 Units on a scale
Standard Deviation 0.45
|
0.10 Units on a scale
Standard Deviation 0.44
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Dyskinesia Baseline
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.33 Units on a scale
Standard Deviation 0.89
|
0.46 Units on a scale
Standard Deviation 1.95
|
0.75 Units on a scale
Standard Deviation 0.96
|
0.17 Units on a scale
Standard Deviation 0.38
|
0.63 Units on a scale
Standard Deviation 1.68
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Dyskinesia Day 84
|
0.10 Units on a scale
Standard Deviation 0.32
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.16 Units on a scale
Standard Deviation 0.90
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.15 Units on a scale
Standard Deviation 0.49
|
0.29 Units on a scale
Standard Deviation 0.72
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Dystonia Baseline
|
0.07 Units on a scale
Standard Deviation 0.26
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.24 Units on a scale
Standard Deviation 0.86
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.03 Units on a scale
Standard Deviation 0.18
|
0.16 Units on a scale
Standard Deviation 0.51
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Parkinsonism Baseline
|
0.13 Units on a scale
Standard Deviation 0.52
|
0.42 Units on a scale
Standard Deviation 1.00
|
1.03 Units on a scale
Standard Deviation 2.36
|
2.20 Units on a scale
Standard Deviation 1.92
|
2.00 Units on a scale
Standard Deviation 3.24
|
2.22 Units on a scale
Standard Deviation 4.15
|
|
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Parkinsonism Day 84
|
0.20 Units on a scale
Standard Deviation 0.63
|
0.33 Units on a scale
Standard Deviation 0.82
|
1.03 Units on a scale
Standard Deviation 2.87
|
0.33 Units on a scale
Standard Deviation 0.58
|
1.15 Units on a scale
Standard Deviation 2.68
|
1.00 Units on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Day 42Population: The pharmacokinetic population consisted of all participants who received at least one dose of study drug and who had data from at least one post-dose sample. It was pre-specified to not summarize and report Part A PK data, which was used only for model building.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=4 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=27 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=28 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of RO6889450
|
157 ng/mL
Geometric Coefficient of Variation 58.7
|
794 ng/mL
Geometric Coefficient of Variation 40.3
|
1550 ng/mL
Geometric Coefficient of Variation 43.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42Population: The pharmacokinetic population consisted of all participants who received at least one dose of study drug and who had data from at least one post-dose sample. It was pre-specified to not summarize and report Part A PK data, which was used only for model building.
Outcome measures
| Measure |
Part A: Monotherapy (Placebo)
n=4 Participants
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=27 Participants
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=28 Participants
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve at Steady State (AUCss) of RO6889450
|
2980 h*ng/mL
Geometric Coefficient of Variation 54.8
|
15100 h*ng/mL
Geometric Coefficient of Variation 43.8
|
28600 h*ng/mL
Geometric Coefficient of Variation 48.4
|
—
|
—
|
—
|
Adverse Events
Part A: Monotherapy (Placebo)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: Monotherapy (150 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Add-on Therapy (Placebo)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Part B: Add-on Therapy (45 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Add-on Therapy (150 mg)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: Add-on Therapy (300 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Monotherapy (Placebo)
n=15 participants at risk
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 participants at risk
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 participants at risk
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 participants at risk
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 participants at risk
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 participants at risk
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
General disorders
Accidental death
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
2.7%
1/37 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
Other adverse events
| Measure |
Part A: Monotherapy (Placebo)
n=15 participants at risk
Participants received placebo each day (QD) for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part A: Monotherapy (150 mg)
n=12 participants at risk
Participants received 150 mg of ralmitaront QD for 12 weeks after a 1-week washout from their usual antipsychotic therapy.
|
Part B: Add-on Therapy (Placebo)
n=37 participants at risk
Participants received placebo QD for 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (45 mg)
n=5 participants at risk
Participants received 45 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (prior to protocol v5; arm was removed thereafter).
|
Part B: Add-on Therapy (150 mg)
n=30 participants at risk
Participants received 150 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy.
|
Part B: Add-on Therapy (300 mg)
n=32 participants at risk
Participants received 300 mg of ralmitaront QD 12 weeks in addition to their usual antipsychotic therapy (after protocol v5).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
20.0%
1/5 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
General disorders
Fatigue
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
2.7%
1/37 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
6.7%
2/30 • Number of events 2 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
20.0%
1/5 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
5.4%
2/37 • Number of events 2 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
10.0%
3/30 • Number of events 3 • Up to Day 84 (Week 12)
|
9.4%
3/32 • Number of events 3 • Up to Day 84 (Week 12)
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • Number of events 2 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
20.0%
1/5 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
20.0%
1/5 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
2.7%
1/37 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
6.7%
2/30 • Number of events 2 • Up to Day 84 (Week 12)
|
3.1%
1/32 • Number of events 1 • Up to Day 84 (Week 12)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
20.0%
1/5 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
8.1%
3/37 • Number of events 3 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
5.4%
2/37 • Number of events 2 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
6.2%
2/32 • Number of events 2 • Up to Day 84 (Week 12)
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
16.7%
2/12 • Number of events 3 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Psychiatric disorders
Libido decreased
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Psychiatric disorders
Schizophrenia
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
16.7%
2/12 • Number of events 2 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
3.1%
1/32 • Number of events 1 • Up to Day 84 (Week 12)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/12 • Up to Day 84 (Week 12)
|
2.7%
1/37 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
3.3%
1/30 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Up to Day 84 (Week 12)
|
8.3%
1/12 • Number of events 1 • Up to Day 84 (Week 12)
|
0.00%
0/37 • Up to Day 84 (Week 12)
|
0.00%
0/5 • Up to Day 84 (Week 12)
|
0.00%
0/30 • Up to Day 84 (Week 12)
|
0.00%
0/32 • Up to Day 84 (Week 12)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER