Clinical trials: Pervasive Development Disorders
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 Disorder
Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
This observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT (fecal matter transplant) therapy and to…
- Trial name
- NCT05465148
- Sponsor
- Viome
Autistic Disorder
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients.
- Trial name
- NCT01474278
- Testing
- RO5028442
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Autistic Disorder
Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions
This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism.
- Trial name
- NCT03919721
- Testing
- Applied Behavioral Analysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Experiad LLC
Autism Spectrum Disorder
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002.
- Trial name
- NCT05889273
- Testing
- ML-004 (IR)/(ER) tablet
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- MapLight Therapeutics
Autistic Disorder
e-Unstuck:Interactive e-Learning Software for Parents to Support Executive Functioning and Behavior Regulation in Children With Autism Spectrum Disorder
The goal of this project is to develop and test e-Unstuck, an e-learning intervention that (1) provides advanced training to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) on how to…
- Trial name
- e-Unstuck (NCT02708069)
- Testing
- e-Unstuck, Unstuck and On Target
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- 3-C Institute for Social Development
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
An Exploratory Open Label Study of EPI-743 (Vincerinone TM) in Children With Autism Spectrum Disorder
The investigators hypothesize that EPI-743 may provide clinical benefit to children with Autism Spectrum Disorder.
- Trial name
- Autism (NCT02226458)
- Testing
- EPI-743
- Sponsor
- Edison Pharmaceuticals Inc
Autism
A Trial of CM-AT in Children With Autism
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism.
- Trial name
- CM-AT (NCT00881452)
- Testing
- CM-AT
- Where
- 19 sites in United States
- Volunteers
- 182 people
- Sponsor
- Curemark
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Rett Syndrome
A Safety Study of NNZ-2566 in Patients With Rett Syndrome
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett Syndrome in adolescent and adult females.
- Trial name
- NCT01703533
- Testing
- NNZ-2566
- Where
- 3 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neuren Pharmaceuticals Limited
Autism Spectrum Disorder, Social Communication Disorder
To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
- Trial name
- NCT06446193
- Testing
- NDTx-01, TAU
- Where
- 5 sites in South Korea
- Volunteers
- 86 people
- Sponsor
- Neudive Inc.
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
Schizophrenia, Autism
Lurasidone Pediatric Pharmacokinetics Study
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric…
- Trial name
- NCT01620060
- Testing
- Lurasidone
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Sumitomo Pharma America, 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.
Autism Spectrum Disorder (ASD)
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
The purpose of this study is to establish the potential benefits, safety, and tolerability of AB-2004 in participants with irritability associated with autism spectrum disorder.
- Trial name
- NCT04895215
- Testing
- AB-2004
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 156 people
- Sponsor
- Vertero Therapeutics
Autism Spectrum Disorder
Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.
- Trial name
- NCT02668991
- Where
- 9 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children
1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD. 2.
- Trial name
- NCT06333964
- Testing
- AST-001
- Where
- 11 sites in South Korea
- Volunteers
- 169 people
- Sponsor
- Astrogen, Inc.
Autism
Safety of L1-79 in Adolescent and Adult Males With Autism
This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days.
- Trial name
- NCT02947048
- Testing
- L1-79
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Yamo Pharmaceuticals LLC
Autism Spectrum Disorder, Gastrointestinal Dysfunction
ASC - Autism Study
The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived…
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells
- Trial name
- NCT05602116
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Cell to Cure ApS