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Autism clinical trials

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NCT ID: NCT03829878 Withdrawn - Clinical trials for Autism Spectrum Disorder

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)

SPROUT
Start date: May 2020
Phase: Phase 2
Study type: Interventional

Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 in subjects with ASD and associated GI symptoms.

NCT ID: NCT03625999 Withdrawn - Clinical trials for Autism Spectrum Disorder

A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech. Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues. Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one. We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.

NCT ID: NCT02414451 Withdrawn - Autism Clinical Trials

Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response

Start date: September 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the effects of propranolol on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.

NCT ID: NCT02094651 Withdrawn - Autism Clinical Trials

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

Start date: April 2014
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT01502488 Withdrawn - Autism Clinical Trials

Adipose Derived Stem Cell Therapy for Autism

Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Autism.

NCT ID: NCT01170325 Withdrawn - Autism Clinical Trials

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

Start date: June 30, 2010
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00873834 Withdrawn - Autism Clinical Trials

Fluoxetine Essay in Children With Autism

FAIR
Start date: September 2009
Phase: Phase 2
Study type: Interventional

This study is a comparative, double blind, placebo controlled trial of 6-months duration designed to evaluate 1) the effects of fluoxetine in 5 to 12 years old autistic children, 2) the effects of fluoxetine on serotoninergic parameters, 3) cerebral metabolic changes (rCBF measurements with PET) induced by the treatment.

NCT ID: NCT00376194 Withdrawn - Autism Clinical Trials

Mercury Chelation to Treat Autism

Start date: September 2006
Phase: Phase 2
Study type: Interventional

This study will examine whether DMSA, an oral chelating agent that removes mercury and other metals from the body, is beneficial for children with autism. DMSA is commonly used to treat autism, although it has never been tested in a controlled study and there is no proof that it helps children with the disorder. Support for its use is based on single-case reports of benefits of chelation with DMSA. This study will help determine whether or not DMSA is useful for treating autism. Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who have not previously received chelation therapy may be eligible for this study. Participants complete a medical history, behavioral and psychological assessment and physical examination. Blood, hair, urine and stool samples are collected for testing. Because DMSA can remove minerals the body needs, such as zinc and iron, as well as the toxic lead and mercury, participants take a daily multivitamin supplement starting 1 month before beginning chelation therapy and continuing for the duration of treatment. After 1 month of the supplementation regimen, the children are assigned to receive DMSA or placebo for 12 weeks, divided into six 2-week cycles. They take the assigned drug 3 times a day on days 1, 2 and 3 of each cycle and continue the multivitamin every day. The children are seen in the clinic immediately before and after the first, third and sixth cycles. At each checkup, the parent or guardian answers a set of questions about the child's autism symptoms, physical health and medication side effects. Blood, urine and stool samples are collected for laboratory testing.