N/A
Completed N=5
Oxcarbazepine Versus Placebo in Childhood Autism
Source: ClinicalTrials.gov NCT00467753 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Vineland Adaptive Behavior Scales
Summary
The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vineland Adaptive Behavior Scales |
— | — |
| PRIMARY Aberrant Behavior Checklist |
— | — |
| PRIMARY Autism Diagnostic Observation Schedule |
— | — |
| PRIMARY Clinical Global Impression Improvement (CGI-AD) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject has autism.
- Subject is between five and seventeen years of age
- Subject is not hospitalized.
Exclusion Criteria
- Subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder.
- Subject has displayed self-injurious behavior.
- Subject has an active seizure disorder or epilepsy.
- Subject has an unstable medical illness.
- Subject has undergone brain injury.
- Subject has a history of diabetes.
- Subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks.
- Subject has used other study drugs within the previous 30 days.
- Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
Data sourced from ClinicalTrials.gov (NCT00467753). 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. Informational only — not medical advice.