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Autistic DisorderPhase 3NCT03487770

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

A Phase 3 study testing Aripiprazole Oral Solution in people with Autistic Disorder, run by Otsuka Beijing Research Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Autistic Disorder
What is being tested?
Aripiprazole Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
1 siteChina
Study dates
9 Apr 2018to 21 Apr 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • 6th affiliated hospital, Peking University

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Flexible-dosed, Placebo-controlled, Parallel-group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Autistic Disorder

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

Read the 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 multiple purposes: to allow for appropriate washout of prohibited medications; to allow for review of screening data; to establish a pre-treatment baseline of key outcome measures.

Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase is to evaluate the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of serious behavioral problems in children and adolescents with a diagnosis of Autistic Disorder..

Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day 16 after the last medication via telephone.

Being tested
Aripiprazole Oral Solution, Placebo Oral Solution
Keywords
Autistic, Aripiprazole Oral Solution
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole Oral SolutionDrug

    Also called Abilify, Aripiprazole

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

  • Placebo Oral SolutionDrug

    Also called Placebo

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

Study groups in NCT03487770
Study groupRoleWhat they receive
Aripiprazole Oral SolutionExperimental1 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;
Receives: Drug: Aripiprazole Oral Solution
Placebo Oral SolutionPlacebo comparator2 ~ 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.
Receives: Drug: Placebo Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and 8 weeks (or endpoint)

Secondary outcomes (3)

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

    The efficacy is assessed by the clinician-rated CGI-I score at Week 8

    Measured: Baseline and 8 weeks (or endpoint)

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

    The efficacy is assessed by changes from Baseline to Week 8 (or endpoint) in Social Withdrawal, Hyperactivity, Stereotypy and Inappropriate Speech Subscale scores of the ABC

    Measured: Baseline and 8 weeks (or endpoint)

  3. Response Rate at Week 8 (or endpoint) (or endpoint)

    The response is defined as a reduction ≥25% in ABC-I score compared to the baseline, and a CGI-I score of much improved or very much improved) at Week 8 (or endpoint).The efficacy is assessed by response rate at Week 8 (or endpoint).

    Measured: Baseline and 8 weeks (or endpoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start9 Apr 2018
  3. Primary completion21 Apr 2020
  4. Study completion21 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487770
Sponsor's protocol ID
031-403-00106
Status last verified
Jan 2020
First submitted
27 Mar 2018
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole Oral Solution in people with Autistic Disorder, run by Otsuka Beijing Research Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from Baseline to Week 8 (or endpoint) in the ABC-I score (time frame: Baseline and 8 weeks (or endpoint)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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