Trial Outcomes & Findings for A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia (NCT NCT01942161)

NCT ID: NCT01942161

Last Updated: 2017-06-28

Results Overview

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

106 participants

Primary outcome timeframe

Baseline (Day 1) and Day 43

Results posted on

2017-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Low (2 mg/Day) Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Overall Study STARTED	35	30	41
Overall Study COMPLETED	27	24	35
Overall Study NOT COMPLETED	8	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Low (2 mg/Day) Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Overall Study Adverse Event	1	2	5
Overall Study Physician Decision	3	1	0
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	3	3	1

Baseline Characteristics

A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	35 Participants n=5 Participants	30 Participants n=7 Participants	41 Participants n=5 Participants	106 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	15.1 years STANDARD_DEVIATION 1.4 • n=5 Participants	15.4 years STANDARD_DEVIATION 1.3 • n=7 Participants	14.7 years STANDARD_DEVIATION 1.3 • n=5 Participants	15.0 years STANDARD_DEVIATION 1.4 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	51 Participants n=4 Participants
Region of Enrollment Japan	35 participants n=5 Participants	30 participants n=7 Participants	41 participants n=5 Participants	106 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 43

Outcome measures

Outcome measures
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score	-19.6 units on a scale Standard Error 3.2	-16.5 units on a scale Standard Error 3.5	-21.6 units on a scale Standard Error 3.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 43

The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.

Outcome measures

Outcome measures
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score	-5.2 units on a scale Standard Error 0.8	-4.9 units on a scale Standard Error 0.9	-5.8 units on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day43

The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score	-0.9 units on a scale Standard Error 0.2	-0.8 units on a scale Standard Error 0.2	-1.0 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and day43

The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score	3.0 units on a scale Standard Error 0.2	3.2 units on a scale Standard Error 0.2	2.7 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 43

The Children's Global Assessment Scale (C-GAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.

Outcome measures

Outcome measures
Measure	Low (2 mg/Day) n=35 Participants Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 Participants Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 Participants Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score	10.5 units on a scale Standard Error 2.0	8.5 units on a scale Standard Error 2.1	8.6 units on a scale Standard Error 1.8

Adverse Events

Low (2 mg/Day)

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Mid (6 - 12 mg/Day)

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

High (24 - 30 mg/Day)

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low (2 mg/Day) n=35 participants at risk Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 participants at risk Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 participants at risk Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Psychiatric disorders Anxiety	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	2.4% 1/41 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Psychiatric disorders Schizophrenia	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	3.3% 1/30 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Psychiatric disorders Suicide attempt	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	3.3% 1/30 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	2.4% 1/41 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)

Other adverse events

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., Ltd

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Low (2 mg/Day) n=35 participants at risk Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks	Mid (6 - 12 mg/Day) n=30 participants at risk Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below. Aripiprazole Mid (6 - 12 mg/day): administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg	High (24 - 30 mg/Day) n=41 participants at risk Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below. Aripiprazole High (24 - 30 mg/day): administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	2.4% 1/41 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Gastrointestinal disorders Constipation	5.7% 2/35 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	7.3% 3/41 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Gastrointestinal disorders Salivary hypersecretion	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	3.3% 1/30 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	14.6% 6/41 • Number of events 6 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Gastrointestinal disorders Nausea	20.0% 7/35 • Number of events 7 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	13.3% 4/30 • Number of events 4 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	22.0% 9/41 • Number of events 11 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
General disorders Malaise	8.6% 3/35 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	4.9% 2/41 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Gastrointestinal disorders Vomiting	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	4.9% 2/41 • Number of events 4 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
General disorders Pyrexia	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	2.4% 1/41 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Infections and infestations Gastroenteritis	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	7.3% 3/41 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Infections and infestations Nasopharyngitis	14.3% 5/35 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	13.3% 4/30 • Number of events 4 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	12.2% 5/41 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Injury, poisoning and procedural complications Contusion	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Investigations Blood creatine phosphokinase increased	5.7% 2/35 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	3.3% 1/30 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Investigations Weight decreased	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	2.4% 1/41 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Investigations Weight increased	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Investigations White blood cell count decreased	5.7% 2/35 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	7.3% 3/41 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	7.3% 3/41 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Akathisia	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/30 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	9.8% 4/41 • Number of events 4 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Dizziness	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	4.9% 2/41 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Dizziness postural	0.00% 0/35 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	3.3% 1/30 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	7.3% 3/41 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Headache	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	9.8% 4/41 • Number of events 8 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Somnolence	14.3% 5/35 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	20.0% 6/30 • Number of events 6 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	12.2% 5/41 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Nervous system disorders Tremor	8.6% 3/35 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	14.6% 6/41 • Number of events 6 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Psychiatric disorders Insomnia	14.3% 5/35 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	20.0% 6/30 • Number of events 6 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	17.1% 7/41 • Number of events 7 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Psychiatric disorders Schizophrenia	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	10.0% 3/30 • Number of events 3 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Epistaxis	5.7% 2/35 • Number of events 4 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	13.3% 4/30 • Number of events 5 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	4.9% 2/41 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Eczema	2.9% 1/35 • Number of events 1 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	6.7% 2/30 • Number of events 2 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)	0.00% 0/41 • From the start date of screening examination to date of the final examination (up to Week 6 at e hours after IMP administration)