Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium
|ClinicalTrials.gov Identifier: NCT02094651|
Recruitment Status : Withdrawn (No eligible patients were enrolled)
First Posted : March 24, 2014
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: divalproex sodium Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: divalproex sodium
divalproex sodium will be administered in sprinkle capsule formulation, target dose of 30mg/kg, drug will be administered for 12 weeks
Drug: divalproex sodium
The drug is an FDA approved medication for seizures but has not been approved for the treatment of epileptiform EEG abnormalities in the absence of clinical seizures.
Placebo Comparator: Placebo
Blue and white capsules with equivalent amount of lactose spheres/beads inside Placebo will be formulated to look identical to the active medication
The placebo is an inactive substance that looks like the active drug.
- effect of drug vs placebo on reduction in epileptiform EEG discharges in children with ASD [ Time Frame: In this crossover study participants will be on drug and placebo for 12 weeks each ]To examine the effect of divalproex sodium (valproate or VPA) on epileptiform EEG discharges in children with ASD. The investigators hypothesize that VPA will significantly reduce discharge counts (primary outcome measure) compared to placebo.
- behavior changes in drug vs placebo. [ Time Frame: In this crossover study participants will be on drug and placebo for 12 weeks each ]To determine if administration of VPA results in improvement in behavior compared to placebo. Based on preliminary data the investigators hypothesize that VPA will be significantly associated with improvement in the areas of aggression, attention and externalizing behaviors as measured by the Child Behavior Checklist (CBCL), the primary behavioral outcome variables. A wide range of other behavioral measures (secondary outcomes) including those related to core ASD symptoms, language, adaptive functioning, sensory and motor behaviors to identify will also be examined. Behavioral measures will be examined in relation to reduction of epileptiform discharges. The investigators will also include both objective and subjective measures of sleep and examine the effect of sleep changes in relation to EEG discharge profiles and behavior.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094651
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Boston Childrens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Sarah Spence, MD PhD||Boston Children’s Hospital|