Trial Outcomes & Findings for A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder (NCT NCT01617447)

NCT ID: NCT01617447

Last Updated: 2017-04-11

Results Overview

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 92 participants
• Primary outcome timeframe: baseline, 8 weeks after dosing
• Results posted on: 2017-04-11

Participant Flow

Participant milestones

Measure	Aripiprazole Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo Placebo were orally administered once daily for 8 weeks.
Overall Study STARTED	47	45
Overall Study COMPLETED	47	42
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Aripiprazole Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo Placebo were orally administered once daily for 8 weeks.
Overall Study Adverse Event	0	1
Overall Study Physician Decision	0	2

Baseline Characteristics

A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Baseline characteristics by cohort

Measure	Aripiprazole n=47 Participants Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo n=45 Participants Placebo were orally administered once daily for 8 weeks.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.3 years STANDARD_DEVIATION 3.3 • n=5 Participants	9.9 years STANDARD_DEVIATION 3.1 • n=7 Participants	10.1 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Japan	47 participants n=5 Participants	45 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 8 weeks after dosing

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.

Outcome measures

Measure	Aripiprazole n=47 Participants Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo n=45 Participants Placebo were orally administered once daily for 8 weeks.
Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score	-11.4 units on a scale Standard Error 1.3	-7.5 units on a scale Standard Error 1.4

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aripiprazole n=47 participants at risk Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo n=45 participants at risk Placebo were orally administered once daily for 8 weeks.
Injury, poisoning and procedural complications Heat illness	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)

Other adverse events

Measure	Aripiprazole n=47 participants at risk Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.	Placebo n=45 participants at risk Placebo were orally administered once daily for 8 weeks.
Gastrointestinal disorders Nausea	6.4% 3/47 • Number of events 3 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Vomiting	6.4% 3/47 • Number of events 3 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Malaise	6.4% 3/47 • Number of events 3 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Gastroenteritis	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	8.9% 4/45 • Number of events 4 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Nasopharyngitis	21.3% 10/47 • Number of events 18 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	24.4% 11/45 • Number of events 12 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Injury, poisoning and procedural complications Contusion	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	6.7% 3/45 • Number of events 6 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Metabolism and nutrition disorders Decreased appetite	12.8% 6/47 • Number of events 6 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Somnolence	51.1% 24/47 • Number of events 25 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	8.9% 4/45 • Number of events 4 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Eye disorders Conjunctivitis allergic	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Constipation	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Dental caries	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Diarrhoea	4.3% 2/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Gastritis	4.3% 2/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Glossitis	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Salivary hypersecretion	4.3% 2/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Toothache	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Gastrointestinal disorders Perianal erythema	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Decreased activity	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Gait disturbance	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Local swelling	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Pyrexia	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
General disorders Thirst	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Immune system disorders Seasonal allergy	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Gingivitis	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Hordeolum	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Influenza	4.3% 2/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	4.4% 2/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Pharyngitis	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Rhinitis	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Sinusitis	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Upper respiratory tract infection	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Enteritis infectious	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Infections and infestations Streptococcal infection	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Injury, poisoning and procedural complications Arthropod bite	2.1% 1/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Injury, poisoning and procedural complications Arthropod sting	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Injury, poisoning and procedural complications Excoriation	2.1% 1/47 • Number of events 4 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Investigations Alanine aminotransferase increased	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Investigations Weight decreased	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Investigations Weight increased	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Metabolism and nutrition disorders Hyperphagia	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Metabolism and nutrition disorders Increased appetite	4.3% 2/47 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Metabolism and nutrition disorders Polydipsia	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Akathisia	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Autism	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Bradykinesia	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Disturbance in attention	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Headache	4.3% 2/47 • Number of events 3 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Sedation	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Speech disorder	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Nervous system disorders Tremor	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Apathy	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Emotional disorder	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Insomnia	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	4.4% 2/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Intentional self-injury	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Sleep disorder	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Parasomnia	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Psychiatric disorders Self injurious behaviour	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Renal and urinary disorders Polyuria	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	4.4% 2/45 • Number of events 4 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Respiratory, thoracic and mediastinal disorders Laryngeal discomfort	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	2.2% 1/45 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Hyperhidrosis	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Miliaria	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Pruritus	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Seborrhoea	2.1% 1/47 • Number of events 1 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	0.00% 0/45 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/47 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)	4.4% 2/45 • Number of events 2 • From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)

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