Phase 3
N=660
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Autistic Disorder · Behavioral Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00365859 ↗Enrolled (actual)
660
Serious AEs
2.7%
Results posted
Jan 2010
Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs |
0; 0; 0; 0; 3; 1 | — |
| PRIMARY Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 |
10.7; 10.6; 11.0; 10.8; -0.3; 0.1 | — |
| PRIMARY Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 |
0.5; 0.5; 0.3; 0.4; -0.3; -0.1 | — |
| PRIMARY Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint |
0.1; 0.2; 0.1; 0.1; -0.1; -0.1 | — |
| PRIMARY Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities |
1; 1; 5; 7; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities |
0; 0; 2; 2; 0; 2 | — |
| PRIMARY Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities |
3; 2; 5; 10; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities |
2; 0; 2; 4; 0; 0 | — |
| PRIMARY Number of Potentially Clinically Relevant Vital Sign Abnormalities |
5; 2; 18; 25; 14; 15 | — |
| PRIMARY Mean Change From Baseline in Patient Weight |
42.5; 45.1; 45.4; 44.6; 0.2; -0.1 | — |
| PRIMARY Mean Change From Baseline by Time Period in Body Weight Z-Score |
0.47; 0.95; 0.98; 0.84; 0.13; 0.10 | — |
| PRIMARY Mean Change From Baseline in Patient Body Mass Index (BMI) |
20.1; 21.0; 21.6; 21.1; 1.7; 1.4 | — |
| PRIMARY Mean Change From Baseline By Time Period in BMI Z-Score |
0.44; 0.98; 1.01; 0.86; 0.17; 0.12 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF) |
4.8; 4.2; 3.9; 4.2; -0.8; -0.4 | — |
| SECONDARY CGI-Improvement Score at Week 52 (Endpoint, LOCF) |
2.7; 2.4; 2.5; 2.5 | — |
| SECONDARY Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF) |
23.2; 21.5; 15.0; 18.5; -6.5; -6.1 | — |
| SECONDARY Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF) |
28.4; 25.8; 18.4; 22.5; -10.0; -8.3 | — |
| SECONDARY Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF) |
8.1; 8.1; 6.4; 7.2; -2.5; -1.9 | — |
| SECONDARY Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF) |
14.6; 11.3; 10.4; 11.7; -5.4; -3.0 | — |
| SECONDARY Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF) |
5.8; 5.7; 4.2; 4.9; -1.9; -1.8 | — |
| SECONDARY Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF) |
12.6; 12.1; 10.4; 11.4; -2.0; -2.4 | — |
Summary
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).
Eligibility Criteria
Inclusion Criteria - Rollover:
- Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 [NCT00332241] or CN138-179 [NCT00337571]
- No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole
Inclusion Criteria - De Novo:
- Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of enrollment
Exclusion Criteria
- Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
- Patients previously treated and not responding to aripiprazole treatment
- The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Data sourced from ClinicalTrials.gov (NCT00365859). 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.