Status:
WITHDRAWN
A Study of Divalproex Sodium in Children With ASD and Epileptiform EEG
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism
Autism Spectrum Disorders
Eligibility:
All Genders
3-10 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Objective The objective of this study is to investigate the efficacy of divalproex sodium in reduction of epileptiform EEG discharges in children with Autism Spectrum Disorders (ASD). ASDs are neurod...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Have a diagnosis of Autistic Disorder, Asperger's syndrome, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS).
- Are aged 3 to 10 years.
- Weigh at least 12.5 kg.
- Only children with frequent epileptiform EEG activity on the overnight EEG at NIH will be randomized to start study drug. Frequent discharges are defined as spikes, spike wave, and sharp waves occurring at greater than 5 events per hour.
- EXCLUSION CRITERIA:
- A diagnosis of epilepsy (past or present) excluding febrile seizures.
- The presence of a severe epileptiform EEG on the sleep EEG at NIH referred to as electrical status epilepticus in sleep (ESES).
- Previous treatment with divalproex sodium
- of greater than 6 months duration
- within the last 12 months
- that was associated with significant side effects leading to termination of treatment.
- Recent (less than two months prior to study entry) initiation of a behavioral therapy program or new psychotropic medication, or the plan to change or start a new therapy.
- Presence of medical condition, such as carnitine deficiency, urea cycle disorder or other metabolic disorder that would be a contraindication to divalproex sodium usage.
- Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by increase above upper limits of normal for BUN/creatinine, or values twice the upper limit of normal for serum transaminases (ALT/SGPT, AST/SGOT), values twice the upper limit of normal for serum lipase and amylase, platelets \< 80,000 /mcL, WBC\< 3.0 10(3)/mcL.
- Pregnancy
- Concomitant use of medication contraindicated with divalproex sodium including topiramate, lamotragine, and drugs that inhibit cytochrome p450 enzymes.
- Behavioral management issues (e.g. self-injury, aggressiveness) that are severe enough to be of safety concerns (to subject and/or staff).
- Absence of primary care physician.
Exclusion
Key Trial Info
Start Date :
June 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01170325
Start Date
June 30 2010
End Date
January 28 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892