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Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism

Intervention: divalproex sodium (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Sarah Spence, MD PhD, Principal Investigator, Affiliation: Children's Hospital Boston

Overall contact:
Emily Pariseau, BS, Email: autismstudy@childrens.org

Summary

The purpose of this study is to determine if treatment of epileptiform abnormalities in children with autism spectrum disorder will improve any behaviors in these children. The investigators will study a number of different behavioral outcomes including behaviors related to attention, social communication, repetitive behaviors, maladaptive behaviors, language, motor and sensory, and sleep. The investigators will use an anticonvulsant medication called valproic acid (in the form of sodium divalproex).

Clinical Details

Official title: Treatment of Children With Autism Spectrum Disorders and Epileptiform EEG With Divalproex Sodium

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: effect of drug vs placebo on reduction in epileptiform EEG discharges in children with ASD

Secondary outcome: behavior changes in drug vs placebo.

Detailed description: Epilepsy and epileptiform EEG abnormalities are common co-morbidities in Autism Spectrum Disorders (ASD) that can be considered important biomarkers of cortical dysfunction in these disorders. They may represent a measure of the excitatory-inhibitory imbalance posited to be involved in the pathogenesis of the disorder. Treatment of epilepsy is always indicated, but treatment of isolated epileptiform EEG (i. e. in the absence of clinical seizures) is frankly controversial. Since data suggest that these epileptiform discharges are associated with deficits in attention, language and behavior, the investigators believe that they may represent an important and novel treatment target in this population. The proposed study brings together a group of investigators long interested in this problem in order to investigate the efficacy of using an anticonvulsant medication with spike suppression capabilities (VPA in the form of divalproex sodium) to treat children with ASD and isolated epileptiform EEGs. Recruiting from 3 large autism centers (Boston Children's Hospital (BCH) and Vanderbilt University (VU) and University of Louisville (U of L)) with very large pediatric epilepsy units, the investigators propose a 26 week randomized placebo controlled cross over study of VPA in 4-8 year old children with ASD with frequent epileptiform EEG discharges.

Eligibility

Minimum age: 4 Years. Maximum age: 8 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female patients aged 4 to 8 years. 2. Diagnosis of with ASD (Autistic Disorder, Asperger's Disorder, or pervasive developmental disorder (PDD-NOS). 3. Frequent epileptiform discharges on EEG (defined as spikes, spike wave, and sharp waves occurring at greater than 15 events per hour). 4. Intelligence quotient (IQ) range 40 to 80. 5. Weight > or = 12. 5 kg. 6. English speaking families Exclusion Criteria: 1. History of epilepsy, known neurogenetic disorder or chromosomal abnormalities with high rates of epilepsy (15q duplication syndrome, 16p deletion/duplication syndrome, Fragile X, tuberous sclerosis complex), or structural brain lesion (prior stroke, migrational defects, brain malformations). 2. The presence of a severe epileptiform EEG on the sleep EEG referred to as electrical status epilepticus in sleep (ESES) in sleep 3. Previous treatment with divalproex sodium that is any one of the following:

- of greater than 6 months duration

- within the last 12 months

- that was associated with significant side effects leading to termination of

treatment 4. Children who have had general anesthesia within the six months or sedation within 2 weeks of study enrollment. 5. 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. 6. Presence of medical condition, such as carnitine deficiency, urea cycle disorder or other metabolic disorder that would be a contraindication to divalproex sodium usage. 7. Presence of a significant untreated medical problem (obstructive sleep apnea, restless legs syndrome, GERD, etc.) which may have significant impact on sleep study measures. 8. Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by values 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. 0 103 /mcL. 9. Concomitant use of medication contraindicated with divalproex sodium including topiramate, lamotrigine, and drugs that inhibit cytochrome p450 enzymes. 10. Behavioral management issues (e. g. self-injury, aggressiveness) severe enough to be of safety concerns (to subject and/or staff). 11. Absence of primary care physician.

Locations and Contacts

Emily Pariseau, BS, Email: autismstudy@childrens.org

University of Louisville, Louisville, Kentucky 40202, United States; Recruiting
Gregory Barnes, MD
Gregory Barnes, MD, Principal Investigator

Boston Childrens Hospital, Boston, Massachusetts 02115, United States; Recruiting
Sarah Spence, MD, PhD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37235, United States; Recruiting
Beth Malow, MD, Principal Investigator

Additional Information

Starting date: April 2014
Last updated: May 20, 2015

Page last updated: August 20, 2015

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