66 completed, 9 terminated, 8 recruiting, 6 unknown. 96 Phase 3, 27 Phase 2.
Follow Child Development Disorders, Pervasive: new trials by email Literature Review of Child Development Disorders, Pervasive trials Research Report on Child Development Disorders, Pervasive
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 |
|---|---|---|---|---|---|---|
| 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 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 |
| 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 |
| Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD Modified Atkin's Diet with standard of care, Standard of Care - Modified Atkins Diet, Autism Spectrum Disorder | Phase 2 / Phase 3 | Unknown | All India Institute of Medical Sciences | 80 | 2024-03-20 | 2024-03-18 |
| Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label N-acetylcysteine - Autism Spectrum Disorder | Phase 2 / Phase 3 | Enrolling by invitation | Stanford University | 144 | 2024-03-12 | 2026-05-15 |
| Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder Lumateperone - Schizophrenia, Bipolar Disorder | Phase 3 | Recruiting | Intra-Cellular Therapies, Inc. | 300 | 2024-01-25 | 2026-11-03 |
| Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD Behavior therapy, Psychoeducation - Autism Spectrum Disorder | Phase 2 / Phase 3 | Unknown | Stanford University | 90 | 2024-01-05 | 2024-08-27 |
| Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders amitriptyline - Autism Spectrum Disorder, Repetitive Compulsive Behavior | Phase 3 | Terminated | University of Missouri, Kansas City | 1 | 2023-11-01 | 2025-05-30 |
| A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children AST-001, Placebo of AST-001 - Autism Spectrum Disorder | Phase 3 | Completed | Astrogen, Inc. | 169 | 2023-08-29 | 2026-02-02 |
| Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders repeated transcranial magnetic stimulation (continuous theta-burst stimulation), sham repeated transcranial magnetic stimulation - Autism Spectrum Disorder | Phase 2 / Phase 3 | Completed | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | 200 | 2023-07-04 | 2026-05-19 |
| Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial N acetyl cysteine, Placebo - Autism Spectrum Disorder | Phase 2 / Phase 3 | Recruiting | Stanford University | 144 | 2023-04-26 | 2026-05-15 |
| Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders PostbiotiX Comfort®, Control - Autism, Autism Disorder | Phase 2 / Phase 3 | Recruiting | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | 90 | 2023-03-21 | 2026-03-04 |
| Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder NTI164 - Autism Spectrum Disorder | Phase 2 / Phase 3 | Completed | Fenix Innovation Group | 54 | 2022-11-30 | 2026-09-10 |
| Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD Cariprazine, Placebo - Autism Spectrum Disorder | Phase 3 | Completed | AbbVie | 161 | 2022-07-07 | 2025-04-04 |
| Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency) Lithium Carbonate, Placebo - Autism Spectrum Disorder | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 22 | 2022-02-21 | 2025-10-02 |
| Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension - Autism Spectrum Disorder, Sleep Disorder | Phase 3 | Unknown | Vanda Pharmaceuticals | 100 | 2021-07-28 | 2024-03-21 |
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Autistic Disorder (66) · Autism Spectrum Disorder (48) · Asperger Syndrome (4) · Schizophrenia (4) · Attention Deficit Disorder with Hyperactivity (3) · Bipolar Disorder (3) · Sleep Wake Disorders (3) · Behavioral Symptoms (2) · Fragile X Syndrome (2) · Marijuana Abuse (2) · Parasomnias (2) · Problem Behavior (2) · Tuberous Sclerosis (2) · Adjustment Disorders (1)
Mental Disorders (96) · Neurodevelopmental Disorders (96) · Autism Spectrum Disorder (45) · Behavior (8) · Neurologic Manifestations (7) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (6) · Genetic Diseases, Inborn (6) · Nervous System Diseases (6) · Pathological Conditions, Signs and Symptoms (6) · Signs and Symptoms (6) · Heredodegenerative Disorders, Nervous System (5) · Congenital Abnormalities (4) · Neurobehavioral Manifestations (4) · Schizophrenia Spectrum and Other Psychotic Disorders (4)
Aripiprazole (8) · Risperidone (5) · Bumetanide (4) · Cycloserine (3) · Melatonin (3) · Oxytocin (3) · Secretin (3) · Sugars (3) · Therapeutics (3) · trospium chloride (3) · xanomeline (3) · Acetylcysteine (2) · Everolimus (2) · Fluoxetine (2) · Lurasidone Hydrochloride (2)
University of California, San Francisco (7) · Indiana University (5) · Massachusetts General Hospital (5) · Otsuka Pharmaceutical Development & Commercialization, Inc. (5) · Curemark (4) · Stanford University (4) · The University of Hong Kong (4) · AbbVie (2) · Bristol-Myers Squibb (2) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (2) · Fenix Innovation Group (2) · Institut de Recherches Internationales Servier (2) · Neurim Pharmaceuticals Ltd. (2) · Neuropharm (2) · Otsuka Pharmaceutical Co., Ltd. (2)
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Robert Hendren, DO (4) · Wong Virginia (4) · Christopher J. McDougle, MD (3) · Gagan Joshi, MD (3) · Robert L Hendren, DO (3) · Deborah Pearson, PhD (2) · John Hegarty, PhD (2) · Paul Wang, M.D. (2) · Abeer Salamah, Dr (1) · Alan Unis, MD (1) · Antonio Y. Hardan, M.D. (1) · Benedetto Vitiello, NIMH Coordinator (1)
PMID 37811711, PMID 21731831, PMID 24138011, PMID 33583058, PMID 36006807, PMID 38032645, PMID 39816573, PMID 15492353, PMID 20973712, PMID 21663425, PMID 21813076, PMID 21818676, PMID 23233021, PMID 23357440, PMID 25878901, PMID 26746121, PMID 26770664, PMID 26802979, PMID 26889605, PMID 27556593, PMID 28138381, PMID 28941259, PMID 28942807, PMID 29096777, PMID 29854372, PMID 31217257, PMID 31267292, PMID 31982581, PMID 32912180, PMID 34324397, PMID 35151410, PMID 35241779, PMID 37267443, PMID 37794745, PMID 41032298, PMID 41198718, PMID 42055586, PMID 42190642
2025 (3), 2017 (2), 2023 (2), 2018 (1), K08MH001516 (1), K23MH068627 (1), K99HD101702 (1), P01HD035465 (1), P01HD035468 (1), R00HD101702 (1), R01HD091972 (1), R01MH072263 (1), R01MH072961 (1), R01MH073524 (1), R01MH077600 (1)