Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01617447
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autistic Disorder
Interventions Drug: Placebo of Aripiprazole
Drug: Aripiprazole
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description 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 were orally administered once daily for 8 weeks.
Period Title: Overall Study
Started 47 45
Completed 47 42
Not Completed 0 3
Reason Not Completed
Adverse Event             0             1
Physician Decision             0             2
Arm/Group Title Aripiprazole Placebo Total
Hide Arm/Group Description 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 were orally administered once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 47 45 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
<=18 years
47
 100.0%
45
 100.0%
92
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 45 participants 92 participants
10.3  (3.3) 9.9  (3.1) 10.1  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
Female
8
  17.0%
9
  20.0%
17
  18.5%
Male
39
  83.0%
36
  80.0%
75
  81.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 47 participants 45 participants 92 participants
47 45 92
1.Primary Outcome
Title Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
Hide Description 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.
Time Frame baseline, 8 weeks after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
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 were orally administered once daily for 8 weeks.
Overall Number of Participants Analyzed 47 45
Mean (Standard Error)
Unit of Measure: units on a scale
-11.4  (1.3) -7.5  (1.4)
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description 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 were orally administered once daily for 8 weeks.
All-Cause Mortality
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Aripiprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      1/45 (2.22%)    
Injury, poisoning and procedural complications     
Heat illness  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J Version 17.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Aripiprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/47 (82.98%)      32/45 (71.11%)    
Eye disorders     
Conjunctivitis allergic  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders     
Nausea  1  3/47 (6.38%)  3 1/45 (2.22%)  1
Vomiting  1  3/47 (6.38%)  3 0/45 (0.00%)  0
Abdominal pain  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Constipation  1  0/47 (0.00%)  0 1/45 (2.22%)  2
Dental caries  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Diarrhoea  1  2/47 (4.26%)  2 0/45 (0.00%)  0
Gastritis  1  2/47 (4.26%)  2 0/45 (0.00%)  0
Glossitis  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Salivary hypersecretion  1  2/47 (4.26%)  2 1/45 (2.22%)  1
Toothache  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Perianal erythema  1  0/47 (0.00%)  0 1/45 (2.22%)  1
General disorders     
Malaise  1  3/47 (6.38%)  3 0/45 (0.00%)  0
Decreased activity  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Gait disturbance  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Local swelling  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Pyrexia  1  1/47 (2.13%)  1 1/45 (2.22%)  1
Thirst  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Immune system disorders     
Seasonal allergy  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Infections and infestations     
Gastroenteritis  1  1/47 (2.13%)  1 4/45 (8.89%)  4
Nasopharyngitis  1  10/47 (21.28%)  18 11/45 (24.44%)  12
Gingivitis  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Hordeolum  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Influenza  1  2/47 (4.26%)  2 2/45 (4.44%)  2
Pharyngitis  1  0/47 (0.00%)  0 1/45 (2.22%)  2
Rhinitis  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Sinusitis  1  0/47 (0.00%)  0 1/45 (2.22%)  2
Upper respiratory tract infection  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Enteritis infectious  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Streptococcal infection  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Injury, poisoning and procedural complications     
Contusion  1  1/47 (2.13%)  1 3/45 (6.67%)  6
Arthropod bite  1  1/47 (2.13%)  2 0/45 (0.00%)  0
Arthropod sting  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Ligament sprain  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Excoriation  1  1/47 (2.13%)  4 1/45 (2.22%)  1
Investigations     
Alanine aminotransferase increased  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Weight decreased  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Weight increased  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  6/47 (12.77%)  6 1/45 (2.22%)  1
Hyperphagia  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Increased appetite  1  2/47 (4.26%)  2 1/45 (2.22%)  1
Polydipsia  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Nervous system disorders     
Somnolence  1  24/47 (51.06%)  25 4/45 (8.89%)  4
Akathisia  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Autism  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Bradykinesia  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Disturbance in attention  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Headache  1  2/47 (4.26%)  3 0/45 (0.00%)  0
Sedation  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Speech disorder  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Tremor  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Psychiatric disorders     
Apathy  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Emotional disorder  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Insomnia  1  0/47 (0.00%)  0 2/45 (4.44%)  2
Intentional self-injury  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Sleep disorder  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Parasomnia  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Self injurious behaviour  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders     
Polyuria  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/47 (2.13%)  1 1/45 (2.22%)  1
Epistaxis  1  1/47 (2.13%)  1 1/45 (2.22%)  1
Upper respiratory tract inflammation  1  0/47 (0.00%)  0 2/45 (4.44%)  4
Laryngeal discomfort  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders     
Eczema  1  0/47 (0.00%)  0 1/45 (2.22%)  1
Hyperhidrosis  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Miliaria  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Pruritus  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Seborrhoea  1  1/47 (2.13%)  1 0/45 (0.00%)  0
Urticaria  1  0/47 (0.00%)  0 2/45 (4.44%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/J Version 17.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01617447    
Other Study ID Numbers: 031-11-002
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: January 4, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017