Trial Outcomes & Findings for A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia (NCT NCT03697252)
NCT ID: NCT03697252
Last Updated: 2020-10-26
Results Overview
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a 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
182 participants
Primary outcome timeframe
Baseline and Week 5
Results posted on
2020-10-26
Participant Flow
The study was conducted in 12 study centers in North America.
A total of 250 participants were screened, 182 were randomized, and 145 participants completed the study.
Participant milestones
| Measure |
KarXT
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
92
|
|
Overall Study
COMPLETED
|
72
|
73
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
| Measure |
KarXT
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
14
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
KarXT
n=90 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7).
On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=92 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 10.12 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 10.08 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 5Population: The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a 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 |
KarXT
n=83 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=87 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
|
-17.40 score on a scale
Standard Error 1.749
|
-5.85 score on a scale
Standard Error 1.668
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The positive symptoms in schizophrenia are the excess or distortion of normal functions such as hallucinations, delusions, grandiosity, and hostility. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Outcome measures
| Measure |
KarXT
n=83 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=87 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
|
-5.62 score on a scale
Standard Error 0.601
|
-2.38 score on a scale
Standard Error 0.573
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: The MITT population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 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.
Outcome measures
| Measure |
KarXT
n=83 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=87 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 2
|
3 Participants
|
1 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 3
|
23 Participants
|
7 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 4
|
13 Participants
|
17 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 6
|
10 Participants
|
9 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 6
|
2 Participants
|
4 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 7
|
0 Participants
|
1 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 4
|
21 Participants
|
21 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Baseline: Score = 5
|
60 Participants
|
60 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 5
|
21 Participants
|
38 Participants
|
|
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Week 5: Score = 7
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: The MITT population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Outcome measures
| Measure |
KarXT
n=83 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=87 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
|
-3.18 score on a scale
Standard Error 0.481
|
-0.90 score on a scale
Standard Error 0.454
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: The MITT population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The Marder Negative Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.
Outcome measures
| Measure |
KarXT
n=83 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=87 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Score
|
-3.85 score on a scale
Standard Error 0.520
|
-1.32 score on a scale
Standard Error 0.492
|
SECONDARY outcome
Timeframe: Week 5Population: The MITT population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
The CGI-S modified asks the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was rated on the following 7-point scale: 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. A CGI-S responder is defined as a participant with a CGI-S scale equal to 1 or 2.
Outcome measures
| Measure |
KarXT
n=72 Participants
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=73 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Percentage of Participants Who Were Clinical Global Impression - Severity of Illness (CGI-S) Responders
|
5.6 percentage of participants
|
1.4 percentage of participants
|
Adverse Events
KarXT
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KarXT
n=89 participants at risk
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7).
On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=90 participants at risk
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
1.1%
1/89 • Number of events 1 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/90 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
KarXT
n=89 participants at risk
Participants received oral Capsule KarXT (xanomeline 125 mg/trospium 30 mg BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium 20 mg BID for the remainder of Week 1 (Days 3 to 7).
On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium 20 mg BID for the remainder of the treatment period.
|
Placebo
n=90 participants at risk
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.9%
15/89 • Number of events 16 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
3.3%
3/90 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
16.9%
15/89 • Number of events 15 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
9.0%
8/89 • Number of events 8 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
1.1%
1/90 • Number of events 1 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.0%
8/89 • Number of events 11 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
8/89 • Number of events 8 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
6.7%
6/89 • Number of events 7 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
5.6%
5/90 • Number of events 5 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
5.6%
5/89 • Number of events 5 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Akathisia
|
3.4%
3/89 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/90 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
3.4%
3/89 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
3.3%
3/90 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Weight increased
|
3.4%
3/89 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
3.4%
3/89 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
2.2%
2/90 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Sedation
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
2.2%
2/90 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/89 • Number of events 3 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
4.4%
4/90 • Number of events 4 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Gamma-Glutamyltransferase increased
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/90 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Agitation
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
1.1%
1/90 • Number of events 1 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
2.2%
2/90 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/90 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
2/89 • Number of events 2 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
1.1%
1/90 • Number of events 1 • From the start of study drug administration up to Week 5
The Safety population included all participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60