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Autistic Disorder in Children and AdolescentsPhase 3NCT01624675

A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

A Phase 3 study testing Risperidone in people with Autistic Disorder in Children and Adolescents, run by Janssen Pharmaceutical K.K. at 17 sites in Japan.

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

The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
17 sitesJapan
Study dates
Sep 2012to Oct 2014
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 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnostic for autistic disorder
  • A Clinical Global Impression - Severity (CGI-S) score of =>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =>18
  • Patients with mental age of >18 months as measured by appropriate developmental or mental scales
  • Patients who have an appropriate caregiver, eg, parent or study-site personnel, who is able to observe the patient's condition, provide information, and evaluate the patient's response appropriately

Who cannot join

  • Patients with previous or current psychotic disorder (eg, schizophrenia, bipolar disorder, or other psychiatric disorders) or with pervasive developmental disorder not otherwise specified, Asperger's disorder, Rett's disorder, pediatric destructive behavior disorder, or substance dependence
  • Patients with a clinically significant endocrine, metabolic, cardiac, hepatic, renal, or pulmonary disorder, or hypertension
  • Weight of <15 kg at the time of screening and baseline
  • Patients with QTc>450 msec in the standard 12-lead electrocardiogram (ECG) at the time of screening
  • Patients with known hypersensitivity to risperidone or paliperidone

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • Study site

    Fuchū

  • Study site

    Fukui

  • Study site

    Hirakata

  • Study site

    Ichikawa

  • Study site

    Kanzaki

  • Study site

    Kobe

  • Study site

    Kodaira

  • Study site

    Kurashiki

  • Study site

    Neyagawa

  • Study site

    Okayama

  • Study site

    Sakai

  • Study site

    Shimotsuke

  • Study site

    Tokyo

  • Study site

    Toyama

  • Study site

    Tsu

  • Study site

    Tsuyama

  • Study site

    Yokohama

Other trials in Japan

About this study

Official title: A Double-blind, Placebo-controlled Study, Followed by an Open-label Extension Study Evaluating the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.

Read the detailed description

This is a randomized (the drug is assigned by chance), 8-week, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), flexible-dose, multicenter study. It will be followed by a 48-week, flexible-dose, open-label (all people know the identity of the intervention) extension, to evaluate the efficacy and safety of risperidone in children and adolescents with a diagnosis of autistic disorder (severe form of pervasive developmental disorder) who have associated irritability. The study consists of up to 2-week screening phase, an 8-week double-blind phase, a 48-week open-label phase, and a 1-week follow-up phase.

Being tested
Risperidone, Placebo
Keywords
Autistic disorder in children and adolescents, Risperidone (R064766), Children, Adolescents, Irritability, Autistic disorder
Medical subject headings
Autistic Disorder

What participants receive

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

  • RisperidoneDrug

    Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.

  • PlaceboDrug

    Subjects will receive placebo matching with risperidone orally up to 8 weeks.

Study groups in NCT01624675
Study groupRoleWhat they receive
RisperidoneExperimentalSubjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
Receives: Drug: Risperidone
PlaceboPlacebo comparatorSubjects will receive placebo matching with risperidone orally up to 8 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores

    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. Higher scores represent worse condition.

    Measured: Baseline, Week 8

Secondary outcomes (10)

  1. The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase

    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.

    Measured: Baseline, Week 2, Week 4, Week 6

  2. The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase

    The ABC-J consists of 58 items divided into 5 subscales: Irritability, Lethargy and Social withdrawal, Stereotypic behavior, Hyperactivity/Noncompliance, and Inappropriate speech. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.

    Measured: Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  3. The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase

    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8

  4. The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the open-label-phase

    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  5. The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of the double-blind phase and open-label-phase

    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.

    Measured: Baseline, Week 4, Week 8

  6. The changes from baseline in scores of the Children's Global Assessment Scale (C-GAS) at each evaluation time point of open-label-phase

    The C-GAS rates the patient's general psychological and social functioning on scores ranging from 1 through 100. Lower scores (range 1-10) mean that the patient needs constant supervision; higher scores (range 91-100) mean that the patient has a superior functioning in all areas.

    Measured: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  7. The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the double-blind phase

    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

    Measured: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8

  8. The Clinical Global Impression-Change (CGI-C) at each evaluation time point of the open label-phase

    The CGI-C assesses the patient's condition on the basis of the rater's impression, on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

    Measured: Week 1, Week 2, Week 3, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48

  9. The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the double-blind phase

    The PSQ evaluates the caregiver's satisfaction with the study drug.

    Measured: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8

  10. The Parent Satisfaction Questionnaire (PSQ) at each evaluation time point of the open label-phase

    The PSQ evaluates the caregiver's satisfaction with the study drug.

    Measured: Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48

Timeline

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

  1. First posted21 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624675
Sponsor's protocol ID
CR100877
Other IDs
RIS-AUT-JPN-01
Status last verified
Oct 2015
First submitted
19 Jun 2012
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PubMed 37811711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risperidone in people with Autistic Disorder in Children and Adolescents, run by Janssen Pharmaceutical K.K. at 17 sites in Japan.

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 4 inclusion and 5 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. 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?

The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (time frame: Baseline, Week 8). 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 NCT01624675, which also lists 1 linked publication.

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 15 Oct 2015.

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