Trial Outcomes & Findings for Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder (NCT NCT01670279)
NCT ID: NCT01670279
Last Updated: 2016-02-04
Results Overview
Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
45 Days
Results posted on
2016-02-04
Participant Flow
This was a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose trial planned in 3 sequential cohorts of elderly participants (70 to 85 years old) with major depressive disorder (MDD). Brexpiprazole was administered as an adjunct treatment to the current antidepressant therapy that the participant received.
The study included a 30-day screening period, a 14-day washout period, up to 45-day inpatient treatment period (titration: received brexpiprazole or placebo once daily \[QD\] for 14 or 21 days and fixed dose phase: received assigned fixed dose for 14 or 28 days), and a 30-day follow-up after the last dose of study drug.
Participant milestones
| Measure |
Brexpiprazole-Cohort 1
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 3
In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
|
Placebo
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
0
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Brexpiprazole-Cohort 1
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 3
In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
|
Placebo
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Participant met withdrawal criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=7 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
76.0 Years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
72.6 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
74.1 Years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 45 DaysPopulation: Tolerability assessed in phase 1 trial in healthy participants (18-45 years) with MDD as adjunct therapy to ADTs; the efficacy assessed in phase 3 trials in participants (18-65 years) with MDD as adjunct therapy to ADTs. Thus, safety/tolerability of brexpiprazole in participants (\>65 years) with MDD as adjunct therapy to ADTs was not characterized.
Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=7 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Number of Participants Who Tolerated Brexpiprazole
|
6 participants
|
7 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Throughout the study, up to 119 daysPopulation: The safety dataset included all randomized participants who received at least one dose of study medication.
The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. AEs were measured throughout the 14-day titration and 28-day fixed dose phase until follow-up (30 \[±2\] days after last dose of study medication).
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Number of AEs Reported.
Adverse events
|
12 Events
|
33 Events
|
5 Events
|
|
Number of AEs Reported.
Serious adverse events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of AEs Reported.
Treatment emergent adverse events (TEAEs)
|
6 Events
|
6 Events
|
3 Events
|
PRIMARY outcome
Timeframe: Titration Day 7, Fixed dose Day 14 and 28 and Last VisitPopulation: The safety dataset included all randomized participants who received at least one dose of study medication.
The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Incidence of Laboratory Values of Potential Clinical Significance
Cholesterol, fasting
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
Glucose
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
Prolactin
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
LDL direct, fasting
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
Triglycerides, fasting
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
Uric acid
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Values of Potential Clinical Significance
Hematocrit
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Titration Day 1, 2, 7, 8, Fixed Days 1, 2, 14, 15, 28, 29, Early Termination and Last Visit.Population: The safety dataset included all randomized participants who received at least one dose of study medication.
The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Incidence of Vital Signs of Potential Clinical Significance
Weight increase
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Vital Signs of Potential Clinical Significance
Supine hypotension, decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Titratrion Day 1 and 7, Fixed dose Day 1, 14, 28, Early TerminationPopulation: The safety dataset included all randomized participants who received at least one dose of study medication.
The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Supraventricular premature beat
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Ventricular premature beat
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Left bundle-branch block
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Myocardial ischemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Symmetrical T-wave inversions
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Increase in QTcB
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of ECG Evaluations of Potential Clinical Significance
Increase in QTcF
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Physical examination was performed at Screening, check-in, and dischargePopulation: Safety Sample was analyzed. Any clinically significant condition present at the post-treatment physical examination that was not present at the baseline examination was documented as an adverse event and followed to a satisfactory conclusion. There were no clinically significant physical examination findings reported in this study.
The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=4 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Incidence of Physical Examination Evaluation of Potential Clinical Significance
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Titration, Day 15, Day 29, Early Termination and Last visitPopulation: Safety Sample includes all randomized participants who receive at least one dose of study medication.
EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The SAS is a rating scale used to measure EPS. The SAS scale 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), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score
End of Titration (N= 6, 6, 4)
|
-0.3 Units on a scale
Standard Deviation 0.5
|
-0.5 Units on a scale
Standard Deviation 0.8
|
-1.0 Units on a scale
Standard Deviation 0.8
|
|
Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score
Day 29 (N=6, 0, 2)
|
-0.3 Units on a scale
Standard Deviation 0.4
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation 0.0
|
|
Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score
Day 15 (N= 0, 5, 2)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.2 Units on a scale
Standard Deviation 0.4
|
-1.5 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score
Early Termination (N= 0, 1, 1)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
-1.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
0.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
|
Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score
Last visit (N= 6, 6, 5)
|
-0.2 Units on a scale
Standard Deviation 0.4
|
0.0 Units on a scale
Standard Deviation 0.6
|
-0.6 Units on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: End of Titration, Day 15, Day 29, Early Termination and Last visitPopulation: Safety Sample includes all randomized participants who receive at least one dose of study medication.
EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The Barnes Akathisia Rating Scale was an EPS rating scale. The Barnes Akathisia Rating Scale was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score
End of Titration (N= 6, 6, 4)
|
-0.2 Units on a scale
Standard Deviation 0.4
|
0.0 Units on a scale
Standard Deviation 0.0
|
-0.5 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score
Day 15 (N= 0, 5, 2)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation 0.0
|
-0.5 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score
Day 29 (N= 6, 0, 2)
|
0.0 Units on a scale
Standard Deviation 0.0
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
-0.5 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score
Early Termination (N= 0, 1, 1)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
0.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
|
Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score
Last visit (N= 6, 6, 5)
|
0.0 Units on a scale
Standard Deviation 0.0
|
0.0 Units on a scale
Standard Deviation 0.0
|
-0.4 Units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: End of Titration, Day 15, Day 29, Early Termination and Last visitPopulation: Safety Sample includes all randomized participants who receive at least one dose of study medication.
EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The AIMS Scale was an EPS rating scale. The AIMS is a 12 item scale. The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.
Last Visit (N= 6, 6, 5)
|
0.0 Units on a scale
Standard Deviation 0.0
|
0.0 Units on a scale
Standard Deviation 0.0
|
0.0 Units on a scale
Standard Deviation 0.0
|
|
Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.
Day 15 (N= 0, 5, 2)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation 0.0
|
0.0 Units on a scale
Standard Deviation 0.0
|
|
Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.
Day 29 (N= 6, 0, 2)
|
0.0 Units on a scale
Standard Deviation 0.0
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation 0.0
|
|
Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.
Early Termination (N= 0, 1, 1)
|
NA Units on a scale
Standard Deviation NA
N=0, data not collected.
|
0.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
0.0 Units on a scale
Standard Deviation NA
N=1, standard deviation is not applicable.
|
|
Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.
End of Titration (N= 6, 6, 4)
|
0.0 Units on a scale
Standard Deviation 0.0
|
0.2 Units on a scale
Standard Deviation 0.4
|
0.0 Units on a scale
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Baseline, End of Titration, Fixed dose Day 14 and 28, Day 15 and 29, Early Termination, Last VisitPopulation: Safety Sample includes all randomized participants who receive at least one dose of study medication.
The C-SSRS was one of the primary parameters to measure the safety and tolerability of individual participants. Suicidality was monitored during the trial using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last trial visit.
Outcome measures
| Measure |
Brexpiprazole-Cohort 1
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 Participants
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 Participants
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Change From Baseline to Study Completion in C-SSRS Score.
Suicidality
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline to Study Completion in C-SSRS Score.
Suicidal behaviour
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline to Study Completion in C-SSRS Score.
Suicidal ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Brexpiprazole-Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Brexpiprazole-Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brexpiprazole-Cohort 1
n=6 participants at risk
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
|
Brexpiprazole-Cohort 2
n=6 participants at risk
In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
|
Placebo
n=5 participants at risk
In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Endocrine disorders
Hyperprolactinaemia
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
33.3%
2/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
33.3%
2/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Investigations
Weight increased
|
33.3%
2/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
50.0%
3/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
20.0%
1/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
2/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
20.0%
1/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Eye disorders
Eye pruritis
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
20.0%
1/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
20.0%
1/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
|
Investigations
Blood pressure
|
16.7%
1/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/6 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
0.00%
0/5 • AEs were captured for all participants from the signing of the informed consent and were measured throughout the 14-day titration period, 28-day fixed dose period until follow-up (30 [±2] days after last dose of study medication).
Participants who had received at least one dose of study medication were included in safety analysis.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place