Clinical trials: Autism Spectrum Disorder
Autism Spectrum Disorder, Developmental Delay
Validation of a Salivary miRNA Diagnostic Test for ASD
This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months.
- Trial name
- NCT05418023
- Testing
- Salivary Collection, Adaptive Assessment, Medical and Demographic questionnaire
- Where
- 16 sites in United States
- Volunteers
- 6,604 people
- Sponsor
- Quadrant Biosciences Inc.
Autism Spectrum Disorders, Stable Clinical Condition in the Last 3 Months
Early Nutritional Intervention in Patients With Autism Spectrum Disorders
Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial effects in patients with autism spectrum disorders (ASD).
- Trial name
- NCT01230359
- Testing
- Pyridoxine hydrochloride, Tang orange powder
- Where
- Qatar
- Volunteers
- 40 people
- Sponsor
- Hamad Medical Corporation
Autism Spectrum Disorder
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04644003
- Testing
- STP1
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stalicla SA
Irritability Associated With Autism Spectrum Disorder, Autism Spectrum Disorder
A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder
Behavior dysregulation is commonly associated with people with autism spectrum disorder (ASD). Irritability is a major safety concern in adults with ASD.
- Conditions
- Irritability Associated With Autism Spectrum Disorder, Autism Spectrum Disorder, ASD
- Trial name
- NCT05733390
- Testing
- JZP541
- Where
- United States
- 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
Autistic Disorder, Behavioral Symptoms
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241]…
- Trial name
- NCT00365859
- Testing
- Aripiprazole
- Where
- 55 sites in United States
- Volunteers
- 330 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.
- Trial name
- NCT03179787
- Testing
- Aripiprazole oral product
- Where
- Japan
- Volunteers
- 528 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Autism
Synthetic Human Secretin in Children With Autism
The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.
- Trial name
- NCT00036244
- Testing
- RG1068 (Synthetic Human Secretin)
- Where
- 15 sites in United States
- Sponsor
- Repligen Corporation
Autism
Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
Allogeneic (not from the subject) human umbilical cord tissue-derived stem cells administered intravenously (IV) in a series of 4 infusions every 3 months over the course of one year is safe and will induce a therapeutic effect…
- Trial name
- NCT02192749
- Testing
- Umbilical cord mesenchymal stem cells
- Where
- Panama
- Volunteers
- 20 people
- Sponsor
- Translational Biosciences
Autism Spectrum Disorder
Treatment Planning for ABA Employing Auxiliary Tools V2+ (TREAAT2+)
Technology enhancement in Applied Behavior Analysis (ABA) treatment planning may increase confidence, efficiency, consistency, and satisfaction for Board Certified Behavior Analysts (BCBAs) which, in turn, can provide for better…
- Trial name
- TREAAT2+ (NCT06204536)
- Testing
- Tech-enabled ABA treatment planning
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Montera Health Texas LLC
Autism Spectrum Disorder
Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)
A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)
- Trial name
- NCT05791071
- Testing
- Floreo VR Building Social Connections
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Floreo, Inc.
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, Autism
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)
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.
- Conditions
- Autism Spectrum Disorder, Autism, ASD, Autistic Thinking
- Trial name
- SPROUT (NCT03829878)
- Testing
- CP101
- Sponsor
- Finch Research and Development LLC.
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, Autistic Disorder
An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum
If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism.
- Conditions
- Autism, Autistic Disorder, Asperger's Disorder, PDD
- Trial name
- NCT02199925
- Testing
- Gammaplex 5%
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Isaac Melamed
Autism Spectrum Disorder, Social Communication Disorder
Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD
The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and…
- Trial name
- NCT07770867
- Testing
- NDTx-03, TAU
- Where
- 7 sites in South Korea
- Volunteers
- 156 people
- Sponsor
- Neudive Inc.
Autism, Autism Spectrum Disorder
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment.
- Trial name
- TECA (NCT07199218)
- Testing
- Terpenes-Enriched CBD-Predominant Oil, Terpenes-Enriched CBD Oil (THC-Free)
- Where
- Israel
- Volunteers
- 78 people
- Sponsor
- Bazelet Nehushtan LtD.
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.
Autism Spectrum Disorder
A Study to Evaluate ARD-501 in Patients With Autism Spectrum Disorder
This is a blinded, placebo controlled, cross-over trial evaluating the safety of two dose-levels of ARD-501 in subjects with ASD.
- Trial name
- NCT06126653
- Testing
- Low Dose ARD-501, High Dose ARD-501
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Aardvark Therapeutics, Inc.
Autism Spectrum Disorder (ASD)
Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD
This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.
- Trial name
- NCT06757504
- Testing
- TTYP01 Tablets (12mg or 18mg)
- Where
- 5 sites in China
- Volunteers
- 150 people
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.