Autism Clinical Trial - Treatment of Children With Autism Spectrum

Status Withdrawn

Clinical Trial 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 Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02094651
Study type	Interventional
Source	Boston Children’s Hospital
Contact
Status	Withdrawn
Phase	Phase 2
Start date	April 2014
Completion date	October 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT04167839` - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Active, not recruiting	`NCT06080087` - Implementation Toolkit to Enhance EBP Among Marginalized Families	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Completed	`NCT05588570` - Coaching Children With Anxiety and Autism Through Telehealth	N/A
Enrolling by invitation	`NCT06058104` - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism	N/A
Completed	`NCT02911194` - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT02847182` - Cord Blood Infusion for Children With Autism Spectrum Disorder	Phase 2
Withdrawn	`NCT02414451` - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response	N/A
Completed	`NCT03002363` - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance	Phase 1
Completed	`NCT02536365` - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness	N/A
Completed	`NCT02720900` - Prebiotic Intervention for Autism Spectrum Disorders	N/A
Completed	`NCT02708290` - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed	`NCT02508922` - Trial of Vitamin D3 Supplementation in Paediatric Autism	N/A
Recruiting	`NCT01836562` - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism	Phase 1/Phase 2
Recruiting	`NCT02255565` - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Phase 4
Completed	`NCT02154828` - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms