Clinical trials: Pervasive Development Disorders
Autism Spectrum Disorder
Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder
This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.
- Trial name
- NCT05626959
- Testing
- NTI164
- Where
- Australia
- Volunteers
- 54 people
- Sponsor
- Fenix Innovation Group
Autistic Disorder
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children…
- Trial name
- NCT03487770
- Testing
- Aripiprazole Oral Solution
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Otsuka Beijing Research Institute
Autistic Disorder, Autism Spectrum Disorder
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral…
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders
- Trial name
- NCT04475848
- Testing
- RO6953958, Midazolam
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
- Trial name
- NCT04156646
- Testing
- Balovaptan, Esomeprazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism Spectrum Disorder
A Multi-site Comparison of Social Visual Engagement to Clinical Diagnosis for Autism Spectrum Disorder
This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference…
- Trial name
- NCT03469986
- Testing
- Marcus Autism Center Investigational Device
- Where
- 6 sites in United States
- Volunteers
- 505 people
- Sponsor
- EarliTec Diagnostics, 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 Spectrum Disorder, Developmental Delay
MAP Autism Prediction Study
This pilot clinical trial tests the hypothesis that certain blood metabolite levels can be used to predict Autism Spectrum Disorder (ASD).
- Trial name
- MAP (NCT04672967)
- Testing
- BioROSA MAP test
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- BioROSA Technologies Inc
Autism, Autism Spectrum Disorder
NTI164 in Autism Spectrum Disorder
This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Disorder
- Trial name
- Beyond Harmony (NCT07257939)
- Testing
- NTI164
- Where
- 3 sites in Australia
- Volunteers
- 200 people
- Sponsor
- Fenix Innovation Group
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
Autism Spectrum Disorder
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.
- Trial name
- NCT04273087
- Testing
- Observation
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Stalicla SA
Alzheimer Disease, Alzheimer Dementia
Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and…
- Conditions
- Alzheimer Disease, Alzheimer Dementia, Vascular Dementia, Lewy Body Disease
- Trial name
- ACIST (NCT03724136)
- Testing
- Intravenous Bone Marrow Stem Cell (BMSC) Fraction, Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction, Near Infrared Light
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 100 people
- Sponsor
- MD Stem Cells
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.
Children18-72 Months With a Suspicion Autistic Disorder
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD.
- Trial name
- NCT05223374
- Testing
- Canvas Dx
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Cognoa, Inc.
Autism Spectrum Disorders
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders
- Trial name
- NCT01288716
- Testing
- Arbaclofen
- Where
- 24 sites in United States
- Volunteers
- 150 people
- Sponsor
- Seaside Therapeutics, Inc.
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
Autism Spectrum Disorder
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum Disorder.
- Trial name
- NCT05516407
- Testing
- FEN164
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Fenix Innovation Group
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, Fra(X) Syndrome
Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
The purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with Autism Spectrum Disorder and Fragile X Syndrome.
- Trial name
- NCT04869930
- Testing
- specimen collection
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Nova Mentis Life Science Corp
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
- 39 sites in United States, Serbia
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.