NCT01170325

A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG

Withdrawn Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Divalproex Sodium in Autism. Withdrawn.

Timeline

30 June 2010

Primary endpoint
28 January 2011

28 January 2011

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	30 June 2010
Primary completion	28 January 2011
Estimated completion	28 January 2011
Sites	1 location across United States

Drugs / interventions tested

• Divalproex Sodium — full drug profile →
• Placebo Comparator

Conditions studied

• Autism — all drugs for Autism →
• Autism Spectrum Disorders — all drugs for Autism Spectrum Disorders →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 3 to 10, any sex, with Autism or Autism Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.