Trial Outcomes & Findings for A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia (NCT NCT05227690)
NCT ID: NCT05227690
Last Updated: 2025-09-17
Results Overview
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
385 participants
Primary outcome timeframe
Baseline through Week 6
Results posted on
2025-09-17
Participant Flow
This trial was conducted at 23 sites in the United States and Bulgaria.
The study included an up to 15-day Screening Period, 45-day Inpatient Treatment Period, and 28-day Follow-up Period. Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment groups (emraclidine 10 mg QD, emraclidine 30 mg QD, or placebo QD), with randomization stratified by geographic region (United States or all other countries).
Participant milestones
| Measure |
Placebo
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
129
|
|
Overall Study
COMPLETED
|
85
|
89
|
92
|
|
Overall Study
NOT COMPLETED
|
43
|
39
|
37
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
10
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
1
|
|
Overall Study
Physician Decision
|
6
|
0
|
4
|
|
Overall Study
Withdrawal of consent
|
28
|
27
|
21
|
|
Overall Study
Other, not specified
|
2
|
2
|
1
|
Baseline Characteristics
A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 11.46 • n=93 Participants
|
40.6 years
STANDARD_DEVIATION 11.28 • n=4 Participants
|
42.5 years
STANDARD_DEVIATION 12.23 • n=27 Participants
|
42.0 years
STANDARD_DEVIATION 11.68 • n=483 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
296 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
330 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
264 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
109 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 6Population: Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Outcome measures
| Measure |
Placebo
n=87 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=90 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=93 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
|
-13.5 units on a scale
Interval -17.0 to -10.0
|
-14.7 units on a scale
Interval -18.1 to -11.2
|
-16.5 units on a scale
Interval -20.0 to -13.1
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was based on the following scale: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative changes from Baseline indicate less mental illness.
Outcome measures
| Measure |
Placebo
n=87 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=90 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=93 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)
|
-0.70 units on a scale
Interval -0.89 to -0.51
|
-0.75 units on a scale
Interval -0.94 to -0.56
|
-0.84 units on a scale
Interval -1.03 to -0.65
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 3, 4, 5, and 6Population: Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=124 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=127 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 1
|
-5.2 units on a scale
Interval -7.3 to -3.0
|
-5.7 units on a scale
Interval -7.8 to -3.6
|
-6.2 units on a scale
Interval -8.3 to -4.1
|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 2
|
-8.7 units on a scale
Interval -11.3 to -6.1
|
-8.8 units on a scale
Interval -11.4 to -6.3
|
-9.0 units on a scale
Interval -11.6 to -6.5
|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 3
|
-10.3 units on a scale
Interval -13.1 to -7.5
|
-10.0 units on a scale
Interval -12.8 to -7.2
|
-11.3 units on a scale
Interval -14.1 to -8.6
|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 4
|
-12.1 units on a scale
Interval -15.3 to -9.0
|
-12.8 units on a scale
Interval -15.9 to -9.6
|
-13.3 units on a scale
Interval -16.4 to -10.2
|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 5
|
-13.2 units on a scale
Interval -16.5 to -9.9
|
-14.0 units on a scale
Interval -17.3 to -10.7
|
-14.7 units on a scale
Interval -18.0 to -11.4
|
|
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score
Week 6
|
-13.5 units on a scale
Interval -17.0 to -10.0
|
-14.7 units on a scale
Interval -18.1 to -11.2
|
-16.5 units on a scale
Interval -20.0 to -13.1
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 3, 4, 5, and 6Population: Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was based on the following scale: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative changes from Baseline indicate less mental illness.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=124 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=127 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 1
|
-0.18 units on a scale
Interval -0.29 to -0.06
|
-0.17 units on a scale
Interval -0.29 to -0.05
|
-0.21 units on a scale
Interval -0.32 to -0.09
|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 2
|
-0.36 units on a scale
Interval -0.5 to -0.21
|
-0.39 units on a scale
Interval -0.54 to -0.25
|
-0.35 units on a scale
Interval -0.5 to -0.21
|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 3
|
-0.48 units on a scale
Interval -0.64 to -0.32
|
-0.42 units on a scale
Interval -0.58 to -0.26
|
-0.52 units on a scale
Interval -0.67 to -0.36
|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 4
|
-0.54 units on a scale
Interval -0.71 to -0.36
|
-0.53 units on a scale
Interval -0.7 to -0.36
|
-0.70 units on a scale
Interval -0.87 to -0.53
|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 5
|
-0.67 units on a scale
Interval -0.85 to -0.49
|
-0.64 units on a scale
Interval -0.82 to -0.46
|
-0.74 units on a scale
Interval -0.92 to -0.56
|
|
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score
Week 6
|
-0.70 units on a scale
Interval -0.89 to -0.51
|
-0.75 units on a scale
Interval -0.94 to -0.56
|
-0.84 units on a scale
Interval -1.03 to -0.65
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Modified Intent-to-Treat population (mITT): All randomized participants who received at least 1 dose of investigational medicinal product (IMP) and have both a Baseline and at least 1 post-Baseline PANSS assessment; participants with available data
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. A PANSS responder is defined as a participant with at least a 30% decrease in PANSS total score compared to Baseline at Week 6 visit or the early termination visit. If a participant discontinued and did not have an early termination visit, the participant's last assessment was considered.
Outcome measures
| Measure |
Placebo
n=127 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=125 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=127 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in Positive and Negative Syndrome Scale [PANSS] Total Score)
|
10.2 percentage of participants
|
17.6 percentage of participants
|
17.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until 28 days following last dose of study drug (up to Week 10)Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAE
|
73 Participants
|
78 Participants
|
82 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAE
|
2 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; from first dose of study drug up to Week 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
12-lead electrocardiogram (ECG) recordings were obtained after the participant had been supine and at rest for at least 3 minutes.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
QTcF value > 450 - 480 msec
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
QTcF value > 480 - 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
QTcF value > 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
QTcF increase from Baseline > 30 - 60 msec
|
13 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
QTcF increase from Baseline > 60 msec
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; from first dose of study drug up to Week 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline; from first dose of study drug up to Week 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Participants' body weights were also measured and recorded.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure < 50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure > 90 mmHg and ≤ 100 mmHg
|
10 Participants
|
9 Participants
|
19 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure < 90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure > 140 mmHg and ≤ 160 mmHg
|
15 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure > 160 mmHg and ≤ 200 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure > 200 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Orthostatic Change in Systolic Blood Pressure ≥ 20 mmHg decrease
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure > 100 mmHg and ≤ 120 mmHg
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure > 120 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Orthostatic Change in Diastolic Blood Pressure ≥ 10 mmHg decrease
|
9 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Heart Rate < 50 bpm
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Heart Rate ≥ 50 bpm and < 60 bpm
|
17 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Heart Rate > 100 bpm and ≤ 120 bpm
|
8 Participants
|
18 Participants
|
24 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Heart Rate > 120 bpm
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Temperature < 36 °C
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Temperature > 38 °C
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Respiratory Rate < 12 breaths/min
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Respiratory Rate > 20 breaths/min
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Body Weight ≥ 7% decrease
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Body Weight ≥ 7% increase
|
16 Participants
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline; from first dose of study drug up to Week 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
The number of participants with clinically significant changes in physical and neurological examination results was documented.
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Clinically Significant Changes in Physical Examination
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Clinically Significant Changes in Neurological Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; from first dose of study drug up to Week 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Outcome measures
| Measure |
Placebo
n=128 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Ideation Compared to Recent History
|
1 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Treatment-Emergent Serious Suicidal Ideation Compared to Recent History
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Emergence of Serious Suicidal Ideation Compared to Recent History
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Emergence of Suicidal Behavior Compared to all Prior History
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 3 and 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data
The SAS consists of a list of 10 symptoms of Parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Negative changes from Baseline indicate an improvement in symptoms.
Outcome measures
| Measure |
Placebo
n=119 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=119 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=125 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline in Simpson Angus Scale (SAS) Total Score
Week 3
|
0.0 units on a scale
Interval -0.1 to 0.1
|
0.0 units on a scale
Interval 0.0 to 0.1
|
0.1 units on a scale
Interval 0.0 to 0.2
|
|
Change From Baseline in Simpson Angus Scale (SAS) Total Score
Week 6
|
0.0 units on a scale
Interval -0.1 to 0.1
|
0.0 units on a scale
Interval -0.1 to 0.1
|
0.0 units on a scale
Interval -0.1 to 0.1
|
SECONDARY outcome
Timeframe: Baseline; Weeks 3 and 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data
The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status. The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from Baseline indicates improvement in the severity of abnormal involuntary movements.
Outcome measures
| Measure |
Placebo
n=119 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=119 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=125 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score
Week 6
|
0.0 units on a scale
Interval -0.1 to 0.1
|
0.0 units on a scale
Interval -0.1 to 0.1
|
0.0 units on a scale
Interval -0.1 to 0.1
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score
Week 3
|
0.0 units on a scale
Interval -0.1 to 0.1
|
-0.1 units on a scale
Interval -0.2 to 0.0
|
0.1 units on a scale
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: Baseline; Weeks 3 and 6Population: Full analysis set: All randomized participants who received at least 1 dose of investigational medicinal product (IMP); participants with available data
The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia. Negative changes from Baseline indicate an improvement in symptoms.
Outcome measures
| Measure |
Placebo
n=119 Participants
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=119 Participants
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=125 Participants
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score
Week 3
|
0.0 units on a scale
Interval -0.1 to 0.0
|
0.0 units on a scale
Interval 0.0 to 0.1
|
0.0 units on a scale
Interval 0.0 to 0.1
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score
Week 6
|
0.0 units on a scale
Interval 0.0 to 0.0
|
0.0 units on a scale
Interval -0.1 to 0.0
|
0.0 units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Emraclidine 10 mg, Once Daily (QD)
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Emraclidine 30 mg, Once Daily (QD)
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=128 participants at risk
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 participants at risk
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 participants at risk
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/129 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
AGGRESSION
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/129 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/129 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
1.6%
2/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/129 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
Other adverse events
| Measure |
Placebo
n=128 participants at risk
Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 10 mg, Once Daily (QD)
n=128 participants at risk
Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
Emraclidine 30 mg, Once Daily (QD)
n=129 participants at risk
Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
|
|---|---|---|---|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
4.7%
6/129 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/129 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.9%
5/128 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
9.3%
12/129 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
3.1%
4/128 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.9%
5/128 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
7.8%
10/129 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/129 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
NAUSEA
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
4.7%
6/129 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
General disorders
FATIGUE
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.9%
5/129 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/129 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Investigations
WEIGHT INCREASED
|
8.6%
11/128 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
17.2%
22/128 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
6.2%
8/129 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.00%
0/129 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.9%
5/129 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
6.2%
8/129 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/128 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/128 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/129 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Nervous system disorders
DIZZINESS
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Nervous system disorders
HEADACHE
|
9.4%
12/128 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
14.1%
18/128 • Number of events 20 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
13.2%
17/129 • Number of events 18 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Nervous system disorders
SOMNOLENCE
|
4.7%
6/128 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
7.0%
9/128 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
7.0%
9/129 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
AGITATION
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.9%
5/129 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
ANXIETY
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
INSOMNIA
|
3.9%
5/128 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
4.7%
6/128 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/129 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
3.1%
4/128 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
2.3%
3/128 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
1.6%
2/129 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
1.6%
2/128 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/129 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
0.78%
1/128 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
3.1%
4/129 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 81.5 days for the Placebo group, 77 days for the Emraclidine 10 mg group, and 80 days for the Emraclidine 30 mg group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place