Phase 3
N=86
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01617460 ↗Enrolled (actual)
86
Serious AEs
11.6%
Results posted
Oct 2017
Primary outcome: Primary: Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score — -3.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score |
-3.2 | — |
Summary
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Eligibility Criteria
Inclusion Criteria
- The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
- The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
- Inpatient or outpatient status
Exclusion Criteria
- The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
- Patients who fall under a contraindication listed in the ABILIFY package insert
- Others
Data sourced from ClinicalTrials.gov (NCT01617460). 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.