Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

NCT03487770 | Completed Phase 3

• 1 other identifier: 031-403-00106
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks

Conditions

Autistic Disorder

Keywords

Autistic; Aripiprazole Oral Solution

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline to Week 8 (or endpoint) in the ABC-I score

  The objective of the primary analysis is to compare the efficacy of aripiprazole flexible-dosed (2 \~ 15 mg/day) with placebo in reducing serious behavioral problems, specifically irritability, agitation and self-injurious behavior, in children and adolescents with a diagnosis of Autistic Disorder. The efficacy is assessed by assessed by change from baseline to endpoint on the Irritability Subscale of the ABC (ABC-I).

  Baseline and 8 weeks (or endpoint)

Secondary Outcomes (3)

• Clinician-rated CGI-I score at Week 8 (or endpoint)

  Baseline and 8 weeks (or endpoint)

• Change in ABC subscale scores from Baseline to Week 8 (or endpoint)

  Baseline and 8 weeks (or endpoint)

• Response Rate at Week 8 (or endpoint) (or endpoint)

  Baseline and 8 weeks (or endpoint)

Study Arms (2)

Aripiprazole Oral Solution

EXPERIMENTAL

1 mg/mL, 2 \~ 15 mg/day (2 \~ 15 mL/day), taken once daily for 8 weeks. Administrate about at the same time each day, either before or after meals;

Drug: Aripiprazole Oral Solution

Placebo Oral Solution

PLACEBO COMPARATOR

2 \~ 15 mg/day (2 \~ 15 mL/day), taken once daily for 8 weeks. Administrate about at the same time each day, either before or after meals.

Drug: Placebo Oral Solution

Interventions

Aripiprazole Oral Solution DRUG

Aripiprazole 2\~15 mg/day (2\~15 mL/day)

Also known as: Abilify, Aripiprazole

Aripiprazole Oral Solution

Placebo Oral Solution DRUG

Placebo 2\~15 mg/day (2\~15 mL/day)

Also known as: Placebo

Placebo Oral Solution

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent must be obtained from a legally authorized guardianprior to the initiation of any protocol-required procedures.
• The subject and/or the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the Investigator.
• The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. In addition, the Childhood Autism Rating Scale (CARS) score is ≥30.
• The subject has a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 AND an ABC-I subscale score ≥18 at screening (Visit 1 or Visit 1a) and baseline (V2).
• Environmental factors can be consistent throughout the trial period.
• The subject is a male or female child or adolescent 6 to 17 years of age (6 ≤ age ≤ 17) at Baseline (V2).

You may not qualify if:

• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
• Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 mIU/mL\].
• Women with a positive pregnancy test or who are pregnant or breastfeeding.
• The subject has a current diagnosis of psychotic disorder such as bipolar disorder, schizophrenia, or depression.
• The subject is currently diagnosed with another disorder on the autism spectrum, including Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Disorder, Rett's Disorder, Childhood Disintegrative Disorder or Fragile-X Syndrome.
• The subject has a history of neuroleptic malignant syndrome.
• The subject represents a significant risk of committing suicide based on history or routine psychiatric status examination.
• The subject has had a seizure in the past year or the electroencephalograph examination is epileptiform discharge at screening.
• The subject has a history of severe head trauma or stroke；
• The subject has a history or current evidence of any unstable medical conditions (eg. history of congenital heart disease or arrhythmia, or cancer) that, in the judgment of the investigator would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
• Non-pharmacological therapy (e.g., psychotherapy, behavior modification, and education training, etc.) could not be stable prior to screening and consistent throughout the study, and the subject who needs to use acupuncture and moxibustion, auditory integration, biofeedback and transcranial magnetic stimulation therapy as supplemental replacement therapy in 7 days prior to taking investigational product or during the course of the trial.
• The subject is considered treatment resistant to antipsychotics medication, in the opinion of the Investigator, based on lack of therapeutic response to 2 different antipsychotics with reasonable doses after treatment of at least 3 weeks each.
• The subjects considered treatment resistant to aripiprazole in the opinion of the investigator based on lack of therapeutic response to an adequate dose and duration of aripiprazole treatment.
• QTc \> 450 msec (male), QTc \> 470 msec (female)
• Platelets (below the lower limit)

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

6th affiliated hospital, Peking University

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Patyman Juma

  Otsuka Beijing Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 4, 2018
• Study Start: April 9, 2018
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)