Clinical trials: Neurodevelopmental Conditions
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.
Dravet Syndrome
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS.
- Trial name
- NCT06660394
- Testing
- LP352
- Where
- 105 sites in United States, Australia and 16 more
- Volunteers
- 108 people
- Sponsor
- Longboard Pharmaceuticals
Healthy, CVA
Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
DELPhI software developed for the analysis of EEG recordings in response to magnetic stimulation in relation to clinical data.
- Conditions
- Healthy, CVA, Hemorrhage, TBI (Traumatic Brain Injury)
- Trial name
- NCT04095377
- Testing
- No intervention, this is a retrospective study.
- Where
- Israel
- Volunteers
- 875 people, healthy volunteers welcome
- Sponsor
- QuantalX Neuroscience
Anxiety Disorders, Childhood Mental Disorder
Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety
Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety…
- Conditions
- Anxiety Disorders, Childhood Mental Disorder, Anxiety
- Trial name
- NCT03269370
- Testing
- Anchors Away, Parent Enhanced Anchors Away, Self-Help E-Book
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Kansas City Center for Anxiety Treatment, P.A.
Inflammatory Bowel Diseases, Depressive Episode
Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years…
- Conditions
- Inflammatory Bowel Diseases, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorder
- Trial name
- NCT05206734
- Testing
- No specific intervention
- Where
- United Kingdom
- Volunteers
- 19,469 people, healthy volunteers welcome
- Sponsor
- Momentum Data
Attention Deficit Hyperactivity Disorder (ADHD), Anxiety Disorders and Symptoms
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD).
- Trial name
- MEGA (NCT06854601)
- Testing
- Mexidol
- Where
- 14 sites in Russia
- Volunteers
- 333 people
- Sponsor
- Pharmasoft
Sleep Disorders, Autism Spectrum Disorder
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
- Trial name
- NPC-15-5 (NCT02757066)
- Testing
- NPC-15 Granules Lower Dose, NPC-15 Granules Higher Dose
- Volunteers
- 196 people
- Sponsor
- Nobelpharma
Fragile X Syndrome
CTH120 First-in-Human Study: Single and Multiple Ascending Doses and Potential Food Interaction
The purpose of this First-in-Human Phase I study is to investigate the safety, tolerability and pharmacokinetics of CTH120 in adult healthy volunteers.
- Trial name
- FIH-CTH120 (NCT06480968)
- Testing
- CTH120
- Where
- Spain
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Connecta Therapeutics, S.L.
Attention Deficit Hyperactivity Disorder, ADHD
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting.
- Trial name
- NCT01269463
- Testing
- Methylphenidate Hydrochloride Extended Release Capsule
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Rhodes Pharmaceuticals, L.P.
Childhood-Onset Fluency Disorder (Stuttering)
Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
- Trial name
- NCT04492956
- Testing
- Ecopipam
- Where
- 9 sites in United States
- Volunteers
- 68 people
- Sponsor
- Emalex Biosciences Inc.
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
Rett Syndrome
Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome
The primary objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of a single intrathecal (IT) dose of TSHA-102 in pediatric females with typical Rett syndrome.
- Trial name
- ASPIRE (NCT07480564)
- Testing
- TSHA-102
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Taysha Gene Therapies, Inc.
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
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, 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.
Dyslexia
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
Studies of dyslexia have shown altered oscillatory activity in the low gamma band (~25-35 Hz) in the left auditory cortex. Neural oscillations around 30 Hz constitute the basic sampling rate of speech, from which the ability to…
- Trial name
- RnDys (NCT05996497)
- Testing
- behavioral measures, Electrophysiological measures, Training 1
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Institut Pasteur
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 Spectrum Disorder, Sleep Disorder
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
- Conditions
- Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
- Trial name
- NCT05361707
- Testing
- Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Vanda Pharmaceuticals
Oral Health, Intellectual Disability
Supervised Brushing Programme for Intellectual Disabled Students
Intellectual disabled persons faced more dental problems. According to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries.
- Conditions
- Oral Health, Intellectual Disability, Randomized Controlled Trial
- Trial name
- NCT03234231
- Testing
- 3-month supervised tooth brushing programme, oral health education talk
- Volunteers
- 602 people
- Sponsor
- MD Equation
Autism, Autistic Disorder
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in…
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases
- Trial name
- NCT00110708
- Testing
- Oralgam (human immunoglobulin)
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- PediaMed Pharmaceuticals