Status:
COMPLETED
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Autistic Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 ...
Detailed Description
Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase will serve mult...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- The following laboratory test results, vital sign and Electrocardiograph (ECG) findings are exclusionary:
- QTc \> 450 msec (male), QTc \> 470 msec (female)
- Platelets (below the lower limit)
- Hemoglobin (below the lower limit)
- Neutrophils (below the lower limit)
- AST (SGOT) or ALT (SGPT) (above the upper limit)
- Creatinine (above the upper limit) In addition, subjects should be excluded if they have any other abnormal laboratory test result, vital sign result or ECG finding that in the investigator's judgment is clinically significant, in that it would impact the safety of the patient or the interpretation of the study results.
- The subject weighs \< 15 kg.
- The subject has a known allergy or hypersensitivity to aripiprazole or other dihydrocarbostyrils (eg. carteolol, vesnarinone, and cilostazol).
- The subject has participated in any clinical trials with an investigational agent within the past month.
- Subjects who are likely to require prohibited concomitant therapy during the trial (refer to Section 7 Prohibited and Restricted Therapies).
- Subjects who participated in a previous clinical trial of aripiprazole (with the exception of Investigator Sponsored Trials).
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2020
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03487770
Start Date
April 9 2018
End Date
April 21 2020
Last Update
December 29 2020
Active Locations (1)
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1
6th affiliated hospital, Peking University
Beijing, Beijing Municipality, China, 100191