Trial Outcomes & Findings for Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD) (NCT NCT04186403)
NCT ID: NCT04186403
Last Updated: 2024-10-03
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity).
COMPLETED
PHASE2/PHASE3
201 participants
Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
2024-10-03
Participant Flow
Participants were enrolled at 55 investigational sites in Spain, Ukraine, and the United States (US) from 13 January 2020 to 22 September 2021.
A total of 203 participants with borderline personality disorder (BPD), who completed the previous double-blind trial (NCT04100096) were screened, out of which 201 participants were enrolled in this study. Of the enrolled participants, 90 received 2 to 3 milligrams per day (mg/day) brexpiprazole and 111 received brexpiprazole matching placebo in the previous double-blind trial.
Participant milestones
| Measure |
Prior Brexpiprazole 2-3 Milligrams Per Day
Participants who received blinded brexpiprazole 2 to 3 milligrams per day (mg/day) in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
111
|
|
Overall Study
Safety Sample
|
88
|
111
|
|
Overall Study
COMPLETED
|
71
|
92
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
| Measure |
Prior Brexpiprazole 2-3 Milligrams Per Day
Participants who received blinded brexpiprazole 2 to 3 milligrams per day (mg/day) in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
Other: Not Related to Covid-19
|
3
|
0
|
Baseline Characteristics
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Baseline characteristics by cohort
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=90 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
72 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)Population: Safety sample included all participants who received at least 1 dose of IMP.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity).
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
TEAEs
|
30 Participants
|
56 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
Mild TEAEs
|
14 Participants
|
37 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
Moderate TEAEs
|
19 Participants
|
30 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
Severe TEAEs
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Screening up to Week 12Population: Safety sample included all participants who received at least 1 dose of IMP. 'Number Analyzed' signifies number of participants with available data for the specified measurement.
Potentially clinically significant ECG abnormalities included rate: Bradycardia (vent \<=50 beats per minute \[bpm\] and decrease \>=15 bpm); Rhythm: Sinus bradycardia (\<=50 bpm and decrease \>=15 bpm), absence during baseline and presence of ventricular premature beat post baseline; ST/T morphology: Absence at baseline and presence of symmetrical T-wave inversion post baseline.
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Ventricular Premature Beat
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Bradycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Sinus Bradycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Symmetrical T-Wave Inversion
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening up to Week 12Population: Safety sample included all participants who received at least 1 dose of IMP.
Potentially clinically significant vital sign abnormalities included: Heart rate standing in bpm (\<50 bpm and decrease \>=15 bpm, \>120 bpm and increase \>=15 bpm); Weight in kilograms (kgs) (decrease \>=7%, increase \>=7%).
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Heart Rate Standing
|
3 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Weight Decreased
|
7 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Weight Increased
|
9 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Screening up to Week 12Population: Safety sample included all participants who received at least 1 dose of IMP. 'Number Analyzed' signifies number of participants with available data for the specified measurement.
Potentially clinically significant laboratory abnormalities included serum chemistry: Prolactin \>upper limit of normal (ULN) (nanograms per millilitre \[ng/ml\] in males and females), fasting glucose ≥100 (milligrams per decilitre \[mg/dl\]), fasting high-density lipoprotein (HDL) cholesterol \<40 (men)/ \<50 (women) (mg/dl), fasting low-density lipoprotein (LDL) cholesterol ≥160 (mg/dl), fasting cholesterol ≥240 (mg/dl), fasting triglycerides ≥150 (mg/dl); Creatine phosphokinase (CPK)/renal: Creatine kinase \>3xULN (units per litre \[U/l\]), creatinine ≥2.0 (mg/dl), urea nitrogen ≥30 (mg/dl).
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Prolactin (ng/ml)-Males
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Glucose, Fasting (mg/dL)
|
13 Participants
|
11 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
HDL Cholesterol, Fasting (mg/dL)
|
22 Participants
|
19 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
LDL Cholesterol, Fasting (mg/dL)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Cholesterol, Fasting (mg/dL)
|
2 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Triglycerides, Fasting (mg/dL)
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=87 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Baseline
|
0.2 score on a scale
Standard Deviation 0.9
|
0.1 score on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
Change From Baseline at Week 12
|
-0.1 score on a scale
Standard Deviation 0.7
|
0.0 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
The AIMS scale 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), dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) (for item 10, no awareness) to 4 (severe condition) (for item 10, awareness, severe distress). AIMS total score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=87 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Baseline
|
0.0 score on a scale
Standard Deviation 0.1
|
0.1 score on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Change From Baseline at Week 12
|
0.0 score on a scale
Standard Deviation 0.2
|
-0.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
The BARS consists of 4 items related to akathisia: Objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The fourth item, global clinical evaluation was rated on a 6-point scale, with a score range of 0 (absence of symptoms) to 5 (severe akathisia). Lower scores indicate less symptoms and negative change from baseline indicate less symptoms.
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=87 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
Baseline
|
0.1 score on a scale
Standard Deviation 0.3
|
0.1 score on a scale
Standard Deviation 0.3
|
|
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
Change From Baseline at Week 12
|
-0.1 score on a scale
Standard Deviation 0.3
|
-0.0 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Safety sample included all participants who received at least 1 dose of IMP.
C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior.
Outcome measures
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 Participants
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 Participants
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
28 Participants
|
28 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0 Participants
|
2 Participants
|
Adverse Events
Prior Brexpiprazole 2-3 mg/Day
Prior Placebo
Serious adverse events
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 participants at risk
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 participants at risk
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
0.90%
1/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.1%
1/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
0.90%
1/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
Other adverse events
| Measure |
Prior Brexpiprazole 2-3 mg/Day
n=88 participants at risk
Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
Prior Placebo
n=111 participants at risk
Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
1.1%
1/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
6.3%
7/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
|
Investigations
Weight increased
|
0.00%
0/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
5.4%
6/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
|
Nervous system disorders
Akathisia
|
1.1%
1/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
8.1%
9/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Insomnia
|
5.7%
5/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
5.4%
6/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Restlessness
|
1.1%
1/88 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
6.3%
7/111 • Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
All-cause mortality: Enrolled sample included all participants who signed an ICF and were enrolled into the trial; Adverse events: Safety sample included all participants who received at least 1 dose of IMP.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place