Trial Outcomes & Findings for A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder (NCT NCT01617460)
NCT ID: NCT01617460
Last Updated: 2024-08-06
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
86 participants
Primary outcome timeframe
Baseline, the final administration
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Aripiprazole
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Aripiprazole
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Physician Decision
|
16
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=86 Participants
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
Age, Categorical
<=18 years
|
86 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
10.0 years
STANDARD_DEVIATION 3.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
|
Region of Enrollment
Japan
|
86 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, the final administrationThe 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=86 Participants
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
|
-3.2 units on a scale
Standard Deviation 8.1
|
Adverse Events
Aripiprazole
Serious events: 10 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=86 participants at risk
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
General disorders
Malaise
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Lymphadenitis bacterial
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Nervous system disorders
Autism
|
2.3%
2/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Psychiatric disorders
Agitation
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Renal and urinary disorders
Glomerulonephritis acute
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
2.3%
2/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Social circumstances
Sexual abuse
|
1.2%
1/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
Other adverse events
| Measure |
Aripiprazole
n=86 participants at risk
Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued.
The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner.
|
|---|---|
|
Eye disorders
Conjunctivitis allergic
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Gastrointestinal disorders
Dental caries
|
9.3%
8/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Gastrointestinal disorders
Nausea
|
7.0%
6/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
7.0%
6/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
12/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
General disorders
Pyrexia
|
9.3%
8/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Bronchitis
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Gastroenteritis
|
11.6%
10/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Influenza
|
29.1%
25/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Nasopharyngitis
|
61.6%
53/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Pharyngitis
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Rhinitis
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
8/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Injury, poisoning and procedural complications
Contusion
|
7.0%
6/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Investigations
Weight increased
|
24.4%
21/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Metabolism and nutrition disorders
Increased appetite
|
11.6%
10/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.1%
7/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Nervous system disorders
Autism
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Nervous system disorders
Headache
|
5.8%
5/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Nervous system disorders
Somnolence
|
32.6%
28/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.5%
9/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.5%
9/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.0%
6/86 • From the start date of investigational medicinal product (IMP) administration to date of the final examination
|
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