Clinical trials: Autism, Early Infantile
Autism
An Open Label Study of CM-AT for the Treatment of Children With Autism
This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
- Trial name
- NCT02649959
- Testing
- CM-AT
- Where
- 31 sites in United States
- Volunteers
- 405 people
- Sponsor
- Curemark
Autism Spectrum Disorder
A Rhythmic and Auditory Approach for Children With Autism Spectrum Disorders (ASD)
The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder.
- Trial name
- THETABOOST (NCT07303413)
- Testing
- EEG recording, Picture recognition test
- Volunteers
- 24 people
- Sponsor
- Institut Pasteur
Autistic Disorder
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
- Trial name
- NCT01617460
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 86 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Autism Spectrum Disorder
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism spectrum disorder (ASD) is a developmental condition that can affect communication, social interaction, and behavior. Identifying ASD early helps children and families access support services sooner.
- Trial name
- APS001 (NCT07903675)
- Testing
- Autism Pupil Screen (APS) Detect PLR Assessment #1, Modified Checklist for Autism in Toddlers, Revised with Follow-up (M-CHAT/R-F), Social Responsiveness Scale, Second Edition (SRS-2)
- Where
- 4 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Schweitzer Engineering Laboratories
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 35 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.
Fragile X Syndrome (FXS), Autism Spectrum Disorder (ASD)
A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS
This is a Study to Investigate the Effects and Safety of Codabakalner for the Treatment of Fragile X Syndrome in Male Participants and Adult Participants with Autism Spectrum Disorders
- Trial name
- NCT07439510
- Testing
- Codabakalner
- Volunteers
- 120 people
- Sponsor
- Spinogenix
Autism
Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction
The purpose of the study is to determine the effect of multiple doses of secretin on autism.
- Trial name
- NCT00036231
- Testing
- RG1068 (Synthetic Human Secretin)
- Sponsor
- Repligen Corporation
Autism Spectrum Disorder
Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder
This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04745026
- Testing
- GWP42003-P
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Jazz Pharmaceuticals
Irritability Associated With Autism Spectrum Disorder
Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors…
- Trial name
- NCT05523895
- Testing
- Pimavanserin
- Where
- 57 sites in United States, Australia and 6 more
- Volunteers
- 237 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Autism Spectrum Disorders
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209…
- Trial name
- NCT01064973
- Testing
- arbaclofen
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Seaside Therapeutics, Inc.
Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder
GroundsKeeper: A Qualitative Study of Applied Game-based Interactives in Special Education Programs
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com).
- Conditions
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Pervasive Developmental Disorder, Asperger's Disorder
- Trial name
- NCT01808066
- Testing
- Groundskeeper
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- CogCubed, Corp
Autism Spectrum Disorder, Sleep Disorder
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
- Conditions
- Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
- Trial name
- NCT05361707
- Testing
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Autistic Disorder
Extended Management and Measurement of Autism
This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine.
- Trial name
- EMMA (NCT00787111)
- Testing
- Fluoxetine (prozac)
- Where
- 13 sites in United States
- Volunteers
- 128 people
- Sponsor
- Neuropharm
Autism Spectrum Disorder, Autism
Treatment Monitoring in Autism Spectrum Disorder (ASD) in Children
The goal of this clinical study is to learn about the utility and performance of the EarliPoint(™) System: Evaluation for Autism Spectrum Disorder to monitor changes in a child's verbal ability, non-verbal learning, and social…
- Conditions
- Autism Spectrum Disorder, Autism, Developmental Delay, Autism, Early Infantile
- Trial name
- MEASURE-ASD1 (NCT05675371)
- Testing
- Assessment by Expert Clinician During Behavioral Intervention (ABA or similar), Assessment by the EarliPoint Assessment For Autism Spectrum Disorder
- Where
- 9 sites in United States
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- EarliTec Diagnostics, Inc
Autism
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
- Trial name
- NCT00872898
- Testing
- Memantine - Extended Release (ER)
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Forest Laboratories
Developmental Disability, Intellectual Disability
Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system.
- Conditions
- Developmental Disability, Intellectual Disability, Autism Spectrum Disorder, Congenital Anomaly
- Trial name
- NCT05295277
- Testing
- Standard of care genetic testing group
- Where
- 8 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Bionano Genomics
Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with…
- Trial name
- NCT07242625
- Testing
- NDTx-02 + TAU, TAU
- Where
- 3 sites in South Korea
- Volunteers
- 48 people
- Sponsor
- Neudive Inc.
Autism Spectrum Disorder (ASD)
TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe…
- Trial name
- NCT07701915
- Testing
- Standard Hospital Care, Telehealth Applied Behavior Analysis (TeleABA)
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Caring Technologies, Inc.
Autistic Disorder, Autism
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Mental Imagery Therapy for Autism (MITA) is a unique, early-intervention application for children with Autism Spectrum Disorder (ASD).
- Conditions
- Autistic Disorder, Autism, ASD
- Trial name
- NCT02708290
- Testing
- MITA Prefrontal Synthesis exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time
- Where
- United States
- Volunteers
- 6,454 people
- Sponsor
- ImagiRation, LLC