53 completed, 8 recruiting, 6 terminated, 6 withdrawn. 84 Phase 2, 18 Phase 1, 9 Phase 3.
Follow Autism: new trials by email Literature Review of Autism trials Research Report on Autism
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 |
|---|---|---|---|---|---|---|
| Role of Omega-DEK in Childhood Apraxia of Speech Omega-DEK, L-carnitine, Placebo - Childhood Apraxia of Speech, Verbal Apraxia | Phase 2 | Not yet recruiting | Claudia R. Morris | 34 | 2026-11-01 | 2026-07-29 |
| 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. Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol - Autism Spectrum Disorder, Autism | Phase 1 / Phase 2 | Enrolling by invitation | Black Tie Medical, Inc. | 50 | 2026-04-30 | 2026-04-27 |
| Xenon Therapy for Children With Autism Spectrum Disorder Xenon - Autism Spectrum Disorder (ASD), Autism | Phase 1 / Phase 2 | Not yet recruiting | The Children's Hospital of Zhejiang University School of Medicine | 72 | 2026-03-01 | 2026-02-27 |
| Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism Terpenes-Enriched CBD-Predominant Oil, Placebo, Terpenes-Enriched CBD Oil (THC-Free) - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Bazelet Nehushtan LtD. | 78 | 2025-10-05 | 2025-11-19 |
| Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Sertraline, Placebo - Neurodevelopmental Disorders, Autism | Phase 2 | Recruiting | Holland Bloorview Kids Rehabilitation Hospital | 130 | 2024-09-16 | 2026-07-27 |
| Trial of Zolpidem for Sleep in Children With Autism Zolpidem, Placebo - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Stanford University | 26 | 2023-08-09 | 2026-03-27 |
| Trial of Diphenhydramine for Sleep in Children With Autism Diphenhydramine, Placebo - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Stanford University | 26 | 2023-08-09 | 2026-03-27 |
| Trial of Suvorexant for Sleep in Children With Autism Suvorexant, Placebo - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Stanford University | 26 | 2023-08-09 | 2026-03-27 |
| Optimizing Outcomes for Young Autistic Children Social Communication, Disruptive Behavior, Social Communication + Reduce Frequency - Autism, Autism Spectrum Disorder | Phase 2 | Active not recruiting | Northwestern University | 184 | 2023-07-11 | 2026-10-19 |
| The Impact of a Virtual Magic Trick Training Program magic trick training - Autism, Pervasive Developmental Disorder | Phase 2 | Recruiting | University of Alabama at Birmingham | 60 | 2023-03-27 | 2026-02-06 |
| 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 |
| A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder L1-79 - Autism Spectrum Disorder, Autism | Phase 2 | Completed | Yamo Pharmaceuticals LLC | 58 | 2022-01-25 | 2024-07-31 |
| hCT-MSC in Children With Autism Spectrum Disorder Cord Tissue Mesenchymal Stromal Cells, Placebo Infusion - Autism, Autism Spectrum Disorder | Phase 2 | Completed | Joanne Kurtzberg, MD | 137 | 2020-10-12 | 2026-06-24 |
| Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism Epidiolex, placebo oral solution - Autism, Autism Spectrum Disorder | Phase 2 | Active not recruiting | University of California, San Diego | 42 | 2020-06-01 | 2025-09-30 |
| Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) CP101, Placebo - Autism Spectrum Disorder, Autism | Phase 2 | Withdrawn | Finch Research and Development LLC. | 2020-05-01 | 2021-04-08 | |
| Parent Telehealth Intervention for Children With Autism Responsive training with no video feedback, Responsive training with video feedback - Autism Spectrum Disorder, Autism | Phase 2 | Completed | Northwestern University | 47 | 2020-03-06 | 2022-01-10 |
| Investigation of Mechanisms of Action in Superpower Glass Superpower Glass - Autism Spectrum Disorder, Autism | Phase 1 / Phase 2 | Terminated | Stanford University | 20 | 2019-09-04 | 2023-09-05 |
| Safety and Efficacy of the Transfusion of UCB in Patients With an ASD Depending on the Degree of HLA Compatibility. ASD CB-MNC infusion low level HLA compatibility., ASD CB-MNC infusion high level HLA compatibility., Standard therapy. - Autism Spectrum Disorder, Autism | Phase 1 / Phase 2 | Unknown | State-Financed Health Facility "Samara Regional Medical Center Dinasty" | 150 | 2019-08-10 | 2023-01-18 |
| A Study of Esomeprazole in Children With Autism Esomeprazole - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Stanford University | 25 | 2019-05-29 | 2026-11-05 |
| Outcomes Mandate National Integration With Cannabis as Medicine Cannabis, Medical, RYAH-Medtech Inhaler - Chronic Pain, Chronic Pain Syndrome | Phase 2 | Unknown | OMNI Medical Services, LLC | 200000 | 2018-12-01 | 2022-06-02 |
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Autistic Disorder (84) · Autism Spectrum Disorder (37) · Asperger Syndrome (11) · Child Development Disorders, Pervasive (10) · Anxiety Disorders (3) · Attention Deficit Disorder with Hyperactivity (3) · Aggression (2) · Fragile X Syndrome (2) · Learning Disabilities (2) · Obsessive-Compulsive Disorder (2) · Tourette Syndrome (2) · Tuberous Sclerosis (2) · 22q11 Deletion Syndrome (1) · Abdominal Pain (1) · Acquired Immunodeficiency Syndrome (1)
Mental Disorders (84) · Neurodevelopmental Disorders (83) · Child Development Disorders, Pervasive (74) · Autism Spectrum Disorder (47) · Nervous System Diseases (7) · Neurologic Manifestations (7) · Behavior (6) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (5) · Genetic Diseases, Inborn (5) · Neurobehavioral Manifestations (5) · Pathological Conditions, Signs and Symptoms (5) · Signs and Symptoms (5) · Behavioral Symptoms (4) · Congenital Abnormalities (4) · Heredodegenerative Disorders, Nervous System (4)
Memantine (4) · Oxytocin (4) · Valproic Acid (3) · Aripiprazole (2) · Carnitine (2) · Risperidone (2) · Standard of Care (2) · Succimer (2) · Transcranial Magnetic Stimulation (2) · 1-(quinoxalin-6-ylcarbonyl)piperidine (1) · Anti-Inflammatory Agents (1) · Arginine Vasopressin (1) · Buspirone (1) · Cannabidiol (1) · Cholecalciferol (1)
Stanford University (8) · Forest Laboratories (5) · National Institute of Mental Health (NIMH) (4) · University of California, San Francisco (3) · Arizona State University (2) · Drexel University College of Medicine (2) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (2) · Joanne Kurtzberg, MD (2) · Northwestern University (2) · State-Financed Health Facility "Samara Regional Medical Center Dinasty" (2) · Sutter Health (2) · Yamo Pharmaceuticals LLC (2) · Ageless Regenerative Institute (1) · Ain Shams University (1) · Alexander Kolevzon (1)
United States (66) · Italy (4) · Belgium (3) · Canada (3) · Colombia (3) · Estonia (3) · France (3) · Hungary (3) · Iceland (3) · New Zealand (3) · Poland (3) · Serbia (3) · South Africa (3) · South Korea (3) · Spain (3)
Antonio Y. Hardan, MD (4) · James B. Adams, PhD (3) · Jordan Lateiner, MS, MBA (3) · Robert L Hendren, DO (3) · Ephraim Katz, PhD (2) · Michael Chez, MD (2) · Richard P Malone, MD (2) · Alexandra Sporn, MD (1) · Ana Carina Tamanaha, Student (1) · Andrew W. Zimmerman, M.D. (1) · Anett Kaale, PhD student (1) · Antonio Hardan, MD (1) · Antonio Y Hardan, MD (1)
PMID 37811711, PMID 36006807, PMID 18315448, PMID 19148734, PMID 20145986, PMID 20406576, PMID 20683766, PMID 21883204, PMID 22151477, PMID 23097920, PMID 23216716, PMID 23357440, PMID 23978163, PMID 24356715, PMID 24472253, PMID 25878901, PMID 27752075, PMID 28374207, PMID 28696286, PMID 30287612, PMID 36353577, PMID 37151032, PMID 38182792, PMID 40410546
P50HD109861 (3), P50HD055784 (1), P50MH100023 (1), R01HD091972 (1), R01MH072263 (1), R01MH073524 (1), R21MH080026 (1), R21NS043979 (1)