A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG
Status:
Withdrawn
Trial end date:
2011-01-28
Target enrollment:
Participant gender:
Summary
Background:
- Electroencephalography (EEG) records electric patterns produced by the brain, and can
detect conditions such as epilepsy or other l abnormalities that may affect brain
function. In EEG studies, electric patterns that resemble epileptic seizures are known
as epileptiform pattern. These patterns are associated with an increased risk of
seizures, even in people who have not been diagnosed with epilepsy. Epileptiform
patterns also appear on the EEGs of some children who have autism spectrum disorders but
do not have epilepsy. It is unclear if these discharges are related in any way to the
symptoms of autism (behavior, language or intellectual abilities).
- Divalproex sodium (Depakote) is a drug that has been used for many years to treat
epilepsy and other brain disorders in children and adults. Researchers are interested
determining whether treatment with divalproex sodium can reduce epileptiform patterns in
children with autism spectrum disorders, and in doing so study whether this treatment
can improve behavior, language or cognition in children with autism spectrum disorders.
Objectives:
- To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges
in children with autism spectrum disorders.
Eligibility:
- Children between 3 and 10 years of age who have an autism spectrum disorder and show
frequent epileptiform discharges on an overnight EEG.
Design:
- This study will last for a total of 9 months, with 6 months of treatment with either
divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium
only.
- Potential participants will be screened with a physical examination and medical history,
blood samples, and psychological tests, and will spend the night in the NIH Clinical
Center to have an overnight EEG. Children with frequent epileptiform abnormalities on
the EEG will continue with the study; all others will be considered ineligible.
- Eligible participants will receive either divalproex sodium or a placebo to be taken
twice daily for 24 weeks. Neither the investigators nor the participants will know which
they are taking.
- Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects
and to test for possible behavioral improvement, and will also have overnight EEG
testing at 12 and 24 weeks.
- At the end of the 24-week study period, participants will have the option to have an
additional 12 weeks of treatment with divalproex sodium.
- A final evaluation (including EEG) will be conducted at the end of the final treatment
period.