Clinical trials: Neurodevelopmental Disability
Child Development, Child Development Disorder
Digital Epidemiology Study on Brain Functioning
Neurobiology has improved the integrative understanding of brain development. With digital technologies, digital (bio)markers would be relevant variables for a better understanding of the heterogeneity of cognitive and behavioral…
- Trial name
- EPIDIA4Kids (NCT05577533)
- Testing
- O-Kidia game battery, O-Brain
- Where
- 2 sites in France
- Volunteers
- 736 people, healthy volunteers welcome
- Sponsor
- O-Kidia
Intellectual Disability, Developmental Delay
Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study
The study uses a randomized controlled study design of pediatric neurologists and developmental pediatricians and front-line (primary care) pediatricians to determine if use of FirstStepDx PLUS and Next StepDx PLUS are associated…
- Trial name
- NCT02414438
- Testing
- FirstStepDX PLUS and NextStepDX PLUS Webinar, FirstStepDX PLUS and NextStepDX PLUS Test Results
- Where
- United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Intellectual Disability, Mild, Intellectual Disability, Mild to Moderate
PGx Medication Safety Reviews of Persons With IDD
The purpose of this study is to assess the feasibility of a comprehensive medication review and PGx initiative as part of the care process for individuals in the care of CP Unlimited.
- Conditions
- Intellectual Disability, Mild, Intellectual Disability, Mild to Moderate, Developmental Disability
- Trial name
- NCT07092852
- Testing
- Cheek swab for PGx testing, Medication safety review
- Where
- 2 sites in United States
- Volunteers
- 700 people
- Sponsor
- GalenusRx, Inc.
Mucopolysaccharidosis (MPS), Hunter Syndrome
Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II)
Hunter syndrome (Mucopolysaccharidosis II, [MPS II]) is a rare, genetically linked lysosomal storage disease (LSD) caused by deficiency of the enzyme, iduronate-2-sulfatase (I2S).
- Trial name
- NCT01822184
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 100 people
- Sponsor
- Shire
Developmental Disabilities, Feeding Disorder
Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay
A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally…
- Trial name
- NCT02912065
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Société des Produits Nestlé (SPN)
Mental Retardation, Developmental Delay
Biomarker for Sanfilippo Type A-B-C-D Disease (BioSanfilippo)
Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of Sanfilippo Disease Type A-B-C-D from blood (plasma)
- Trial name
- BioSanfilippo (NCT02298686)
- Where
- 5 sites in Egypt, Germany and 2 more
- Sponsor
- CENTOGENE GmbH Rostock
Rett Syndrome
A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)
The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the…
- Trial name
- NCT05606614
- Testing
- TSHA-102
- Where
- 9 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Taysha Gene Therapies, 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
Dyslexia, Reading Disability
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
This study investigates whether transcranial electrical stimulation (tES) delivered during structured reading instruction affects reading proficiency in children with developmental dyslexia and related reading disabilities.
- Trial name
- NCT07762365
- Testing
- Active transcranial electrical stimulation (tES)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- General Neuro 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
Learning Disorder, Specific, Learning Disabilities
Rhythm Training of a Serious Game on the Reading Skills of Children w/ a Specific Learning Disorder Impacting Reading
Mila-Learn-01 is a double-blind clinical study (meaning that neither the patient nor the doctor or his/her team will know which game the child has), which enables us to see the effect of a serious game on the child's reading…
- Conditions
- Learning Disorder, Specific, Learning Disabilities, Dyslexia, Specific Learning Disorder, With Impairment in Reading
- Trial name
- NCT05154721
- Testing
- experimental Group - Mila-Learn
- Where
- 3 sites in France
- Volunteers
- 151 people
- Sponsor
- Poppins
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
Asperger's Syndrome, Dyslexia
My Scrivener® - Measuring Effectiveness and Dose Response in Children
This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.
- Conditions
- Asperger's Syndrome, Dyslexia, Cerebral Palsy, Attention Deficit Disorder
- Trial name
- NCT00919906
- Testing
- My Scrivener(R)
- Where
- United States
- Volunteers
- 176 people
- Sponsor
- Obslap Research LLC
Learning Disorders, Child Behavior Disorders
A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
The purpose of this study is to assess whether risperidone (an antipsychotic medication) is safe and effective in treating behaviour disorder in learning disabled children, which does not improve with psychological therapy.
- Trial name
- NCT00254930
- Testing
- risperidone
- Volunteers
- 19 people
- Sponsor
- Janssen-Cilag Ltd.
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi
Mucopolysaccharidosis Type II, Metabolic Diseases
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
This is phase 2/3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.
- Trial name
- NCT05208281
- Testing
- GNR-055 1.0-2.0-3.0 mg/kg, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg
- Where
- 5 sites in Russia
- Volunteers
- 32 people
- Sponsor
- AO GENERIUM
Attention-deficit Hyperactivity Disorder
A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
The purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective…
- Trial name
- NCT01624649
- Testing
- Methylphenidate hydrochloride, Atomoxetine
- Where
- 9 sites in South Korea
- Volunteers
- 289 people
- Sponsor
- Janssen Korea, Ltd., Korea
Abuse Prevention
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.
- Trial name
- AP4ID (NCT03998605)
- Testing
- Abuse Prevention Program, Control Condition
- Where
- United States
- Sponsor
- Double S Instructonal Systems
Fragile X Syndrome, Autism
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism. CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength.
- Trial name
- NCT00054730
- Testing
- CX516 (Ampalex®)
- Where
- 2 sites in United States
- Sponsor
- RespireRx
Intellectual Disability, Developmental Delay
Biomarker for Creatine Deficiency Syndromes (BioCDS)
Development of a new mass spectrometry-based biomarker for the ear-ly and sensitive diagnosis of the Creatine Deficiency Syndromes from dry-blood-spot sample
- Conditions
- Intellectual Disability, Developmental Delay, Movement Disorder, Behavioral Disorder
- Trial name
- BioCDS (NCT02934854)
- Where
- 4 sites in Egypt, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock