Clinical trials: Autism Spectrum Disorders (ASD)
Autism, Autism Spectrum Disorder
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Trial name
- NCT07590973
- Testing
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Blinklab Limited
Autism
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.
- Trial name
- NCT02140112
- Testing
- Trichuris suis ova
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- Coronado Biosciences, Inc.
Autism Spectrum Disorder
NeuroCytotron in the Treatment of Autism Spectrum Disorder
Preliminary Efficacy and Feasibility of Using NeuroCytotron in the Treatment of Autism Spectrum Disorder
- Trial name
- NCT06477263
- Testing
- Neurocytotron
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- Neurocytonix, Inc.
Autism Spectrum Disorder
International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
- Trial name
- NCT05590715
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Stalicla SA
Fragile X Syndrome
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
- Trial name
- Harbor-A (NCT01282268)
- Testing
- arbaclofen
- Where
- 24 sites in United States
- Volunteers
- 125 people
- Sponsor
- Seaside Therapeutics, Inc.
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
Agitation in Adolescents and Young Adults With ASD
INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
This is a Phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder…
- Trial name
- CALM 201 (NCT05163717)
- Testing
- INP105
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Impel Pharmaceuticals
Autism Spectrum Disorder
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
- Trial name
- NCT06473623
- Testing
- vagus nerve stimulation
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Neuropix
Sleep Disorders
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy…
- Trial name
- NCT01906866
- Testing
- Circadin 2/5/10 mg
- Where
- 28 sites in United States, Finland and 3 more
- Volunteers
- 125 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Autism Spectrum Disorder (ASD)
A Repeatability and Reproducibility Study of the EarliPoint™ Device
The study is a prospective randomized repeatability and reproducibility (R\&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age.
- Trial name
- RnR (NCT04860986)
- Testing
- EarliPoint
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- EarliTec Diagnostics, Inc
Autism Spectrum Disorder
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in…
- Trial name
- NCT02414503
- Testing
- 8IU intranasal oxytocin, 24IU intranasal oxytocin, OptiNose Breath Powered Bi
- Where
- Norway
- Volunteers
- 17 people
- Sponsor
- OptiNose AS
Autistic Disorder in Children and Adolescents
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
The purpose of this study is to evaluate the efficacy of risperidone compared with placebo in children and adolescents with irritability associated with autistic disorder.
- Trial name
- NCT01624675
- Testing
- Risperidone
- Where
- 17 sites in Japan
- Volunteers
- 39 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
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.
Autism
Lurasidone Pediatric Autism Study
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent…
- Trial name
- NCT01911442
- Testing
- Lurasidone 20 mg daily, Lurasidone
- Where
- 41 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sumitomo Pharma America, Inc.
Autism
SynapDx Autism Gene Expression Analysis Study (STORY)
This study will prospectively enroll approximately 880 children, at least 18 months and less than 60 months of age, who have been referred to a pediatric developmental evaluation center.
- Trial name
- STORY (NCT01810341)
- Where
- 20 sites in United States, Canada
- Volunteers
- 880 people
- Sponsor
- SynapDx
Bi-Polar Disorder, Autism Spectrum Disorder (ASD)
An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
- Conditions
- Bi-Polar Disorder, Autism Spectrum Disorder (ASD), Major Depression Disorders, Separation Anxiety Disorder
- Trial name
- NCT07329673
- Testing
- Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Qbtech AB
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07284745
- Testing
- KarXT, KarX-EC
- Where
- 39 sites in United States, Australia and 2 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Autism Spectrum Disorder
Efficacy and Safety of Functional Neurogenesis Stimulation Therapy in Children With Autism Spectrum Disorder (ASD)
This study will test whether a noninvasive brain stimulation treatment called Functional Neurogenesis Stimulation (using the NeuroCytontron device) can safely improve core symptoms of Autism Spectrum Disorder (ASD) in children.
- Trial name
- NCT07276555
- Testing
- Functional Neurogenesis Stimulation Therapy
- Where
- 2 sites in United States, Mexico
- Volunteers
- 256 people
- Sponsor
- Neurocytonix, Inc.