Phase 4
N=157
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
Irritability Associated With Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01227668 ↗Enrolled (actual)
157
Serious AEs
0.4%
Results posted
May 2014
Primary outcome: Primary: Percentage of Patients Relapsing by Week 16 — 32; 50 Percentage of participants — p=0.097
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aripiprazole (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Relapsing by Week 16 |
32; 50 | 0.097 |
| SECONDARY Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF]) |
5.2; 9.6 | 0.051 |
| SECONDARY Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF]) |
4.2; 4.8 | 0.090 |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1 |
0; 1; 13 | — |
Summary
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo
Eligibility Criteria
Key Inclusion Criteria
- Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit
- Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental Disorders IV-Text Revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised.
- Participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
- Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems
- An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global Impressions Severity score ≥4 at the Screening and Baseline Visits.
- Mental age of at least 24 months
Key Exclusion Criteria
- Treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each.
- Previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response.
- Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
- Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome
- History of neuroleptic malignant syndrome
- At significant risk for suicide based on history or routine psychiatric status examination
- A seizure within the past year
- History of severe head trauma or stroke
- History or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
- Weight lower than 15 kg
- Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils
- History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
- Any other medically significant abnormal laboratory test or vital sign result or electrocardiogram finding
Data sourced from ClinicalTrials.gov (NCT01227668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.