306 completed, 23 recruiting, 23 terminated, 16 unknown. 395 Phase 3, 64 Phase 2.
Follow Neurodevelopmental Disorders: new trials by email Literature Review of Neurodevelopmental Disorders trials Research Report on Neurodevelopmental Disorders
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support Academic Competency Enhancement (ACE) classroom, School as Usual Classroom Supports - Attention Deficit Hyerpactivity Disorder | Phase 2 / Phase 3 | Not yet recruiting | Florida International University | 544 | 2027-01-01 | 2026-09-28 |
| A Study to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS Codabakalner, Placebo - Fragile X Syndrome (FXS), Autism Spectrum Disorder (ASD) | Phase 2 / Phase 3 | Not yet recruiting | Spinogenix | 120 | 2026-12-01 | 2026-10-09 |
| A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Recruiting | Bristol-Myers Squibb | 176 | 2026-10-06 | 2026-11-10 |
| A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo - Irritability Associated With Autism Spectrum Disorder | Phase 3 | Recruiting | Bristol-Myers Squibb | 176 | 2026-10-06 | 2026-11-10 |
| NTI164 in Autism Spectrum Disorder NTI164, Placebo - Autism, Autism Spectrum Disorder | Phase 3 | Not yet recruiting | Fenix Innovation Group | 200 | 2026-09-30 | 2026-09-30 |
| Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations Everolimus blinded oral capsules, Placebo - Cowden's Disease, Cowden's Syndrome | Phase 2 / Phase 3 | Not yet recruiting | Boston Children's Hospital | 60 | 2026-09-01 | 2026-06-04 |
| A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation Centanafadine XR - Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 80 | 2026-09-01 | 2026-11-06 |
| An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Solriamfetol - ADHD | Phase 3 | Enrolling by invitation | Axsome Therapeutics, Inc. | 300 | 2026-08-06 | 2026-11-06 |
| Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Solriamfetol Dose A, Solriamfetol Dose B, Placebo - ADHD | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 468 | 2026-07-06 | 2026-11-06 |
| A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD AK-D101, Placebo - Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder | Phase 3 | Not yet recruiting | Alvogen Korea | 156 | 2026-07-01 | 2026-07-02 |
| Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) Solriamfetol Dose A, Solriamfetol Dose B, Placebo - ADHD | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 468 | 2026-06-25 | 2026-11-06 |
| Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome TSHA-102 - Rett Syndrome | Phase 3 | Active not recruiting | Taysha Gene Therapies, Inc. | 4 | 2026-05-08 | 2026-08-19 |
| A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents KarXT, KarX-EC - Schizophrenia, Autism-Related Irritability | Phase 3 | Recruiting | Karuna Therapeutics, Inc., a Bristol Myers Squibb company | 400 | 2026-04-07 | 2026-11-06 |
| Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial Xylitol Chewing gum, Sorbitol chewing gum - Preterm Birth, Low Birthweight Neonate | Phase 2 / Phase 3 | Recruiting | University of Washington | 6000 | 2026-03-26 | 2026-09-10 |
| Reducing Missed Appointments Reminder message and patient navigation - Neurodevelopmental Disorders | Phase 3 | Recruiting | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | 5000 | 2025-12-29 | 2026-03-18 |
| Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th Arbaclofen, Placebo - Autism Spectrum Disorders | Phase 3 | Recruiting | Hospital General Universitario Gregorio Marañon | 103 | 2025-11-20 | 2026-06-17 |
| PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury Ceftriaxone 2g diluted in >200ml 0.9%sodium chloride, Placebo comparator - no ceftriaxone - All-cause Mortality, Quality of Life | Phase 3 | Recruiting | The George Institute | 3300 | 2025-10-30 | 2026-08-28 |
| A Long-term Trial of EB-1020 in Pediatric Patients With ADHD EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose - Attention-Deficit Hyperactivity Disorder(ADHD) | Phase 3 | Recruiting | Otsuka Pharmaceutical Co., Ltd. | 180 | 2025-09-16 | 2025-12-23 |
| A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose, Placebo - Attention-Deficit Hyperactivity Disorder(ADHD) | Phase 2 / Phase 3 | Recruiting | Otsuka Pharmaceutical Co., Ltd. | 315 | 2025-09-03 | 2025-12-23 |
| TAP-GRIN: Interventional Study on Patients With GRIN-related Neurodevelopmental Disorders L-serine, Maltodextrin (Placebo) - GRIN-related Disorders, GRIN1 | Phase 3 | Recruiting | Meyer Children's Hospital IRCCS | 40 | 2025-08-29 | 2026-01-29 |
Showing 20 of 395. Sign in to see all of them.
Attention Deficit Disorder with Hyperactivity (228) · Autistic Disorder (66) · Autism Spectrum Disorder (48) · Tourette Syndrome (21) · Intellectual Disability (15) · Mental Disorders (10) · Spasm (10) · Tic Disorders (10) · Anxiety Disorders (9) · Child Development Disorders, Pervasive (9) · Oppositional Defiant Disorder (9) · Nervous System Diseases (8) · Conduct Disorder (7) · Attention Deficit and Disruptive Behavior Disorders (6)
Mental Disorders (385) · Attention Deficit and Disruptive Behavior Disorders (230) · Child Development Disorders, Pervasive (87) · Nervous System Diseases (67) · Pathological Conditions, Signs and Symptoms (52) · Signs and Symptoms (51) · Autism Spectrum Disorder (45) · Neurologic Manifestations (44) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (36) · Genetic Diseases, Inborn (33) · Central Nervous System Diseases (32) · Brain Diseases (31) · Heredodegenerative Disorders, Nervous System (30) · Neurobehavioral Manifestations (26)
Methylphenidate (46) · Atomoxetine Hydrochloride (29) · Aripiprazole (15) · Lisdexamfetamine Dimesylate (14) · Risperidone (11) · 1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane (10) · Guanfacine (9) · 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine (6) · Melatonin (6) · Sugars (6) · Amphetamine (5) · SLI381 (5) · Therapeutics (5) · Bumetanide (4) · Dexmethylphenidate Hydrochloride (4)
Shire (29) · Eli Lilly and Company (24) · Otsuka Pharmaceutical Development & Commercialization, Inc. (18) · Supernus Pharmaceuticals, Inc. (12) · Sumitomo Pharma America, Inc. (10) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (7) · Massachusetts General Hospital (7) · Rhodes Pharmaceuticals, L.P. (7) · University of California, San Francisco (7) · Otsuka Pharmaceutical Co., Ltd. (6) · Indiana University (5) · New York State Psychiatric Institute (5) · Novartis (5) · Noven Therapeutics (5) · University of Cincinnati (5)
United States (237) · Canada (42) · Germany (37) · France (30) · Italy (27) · Spain (27) · United Kingdom (24) · Japan (19) · Belgium (18) · Hungary (17) · Netherlands (16) · Poland (16) · Australia (15) · Sweden (15) · South Korea (13)
Ann Childress, MD (5) · Eva Kohegyi, MD (5) · Jonathan Rubin, MD (4) · Joseph Reiz (4) · Nobuhito Sanada (4) · Robert Hendren, DO (4) · Wong Virginia (4) · Christopher J. McDougle, MD (3) · Gagan Joshi, MD (3)
PMID 37811711, PMID 25019647, PMID 33600233, PMID 33971070, PMID 34523063, PMID 36847750, PMID 35201607, PMID 36971690, PMID 37058600, PMID 38824626, PMID 41342306, PMID 11394191, PMID 18974308, PMID 20732631, PMID 20861587, PMID 21367347, PMID 21432592, PMID 21731831, PMID 21824454, PMID 24138011, PMID 24565357, PMID 25266438, PMID 25721183, PMID 27082828, PMID 33583058, PMID 34057707, PMID 34637343, PMID 34714112, PMID 36006807, PMID 38032645, PMID 38723617, PMID 39816573, PMID 41697570, PMID 42779129, PMID 10917410, PMID 11389303, PMID 11581440, PMID 12153826, PMID 12218423, PMID 12578439, PMID 12849360, PMID 15026214, PMID 15212606, PMID 15328899, PMID 15492353, PMID 15965209, PMID 16102908, PMID 16175106, PMID 16389216, PMID 16456216
2023 (4), 2008 (3), 2016 (3), 2017 (3), 2025 (3), 2009 (2), U10DA013732 (2), 2018 (1), K08MH001516 (1), K23MH068627 (1), K99HD101702 (1), P01HD026927 (1), P01HD035465 (1), P01HD035468 (1), R00HD101702 (1)