166 completed, 27 recruiting, 19 unknown, 18 terminated. 271 Phase 2, 35 Phase 1, 27 Phase 3.
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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 |
|---|---|---|---|---|---|---|
| Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism Ganaxolone (Ztalmy), Placebo - Autism in Children, Autistic Disorder in Children and Adolescents | Phase 2 | Not yet recruiting | Stanford University | 66 | 2027-01-01 | 2026-11-05 |
| 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 |
| 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 |
| Heart Rate Variability Biofeedback for Anxiety in Autistic Youth Lief Smart Patch - Autism Spectrum Disorder, Anxiety | Phase 2 | Recruiting | Massachusetts General Hospital | 50 | 2026-10-26 | 2026-10-16 |
| Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders ILT-101 ld-(IL2), NaCl (0,9%) - Autism Spectrum Disorder | Phase 2 | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 22 | 2026-10-01 | 2026-05-15 |
| TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS PPF3, Placebo - Autism Disorder | Phase 2 | Recruiting | Holland Bloorview Kids Rehabilitation Hospital | 100 | 2026-10-01 | 2026-10-29 |
| 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 Placebo-controlled Trial of Folinic Acid in Children With ASD Folinic Acid, Placebo - Autism Spectrum Disorder | Phase 2 | Recruiting | Prof. Adi Aran | 150 | 2026-06-23 | 2026-06-22 |
| 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 |
| Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners ALLSTAR - Literacy, Communication, Nonverbal | Phase 1 / Phase 2 | Not yet recruiting | Penn State University | 60 | 2026-03-01 | 2026-02-03 |
| Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism Propranolol, Placebo - Autism Spectrum Disorder, Challenging Behaviour | Phase 2 | Recruiting | Jeremy Veenstra-vanderweele | 60 | 2026-01-30 | 2026-09-01 |
| A Phase 2A Trial of DT402 for Autism Spectrum Disorder DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) - Autism Spectrum Disorder, ASD | Phase 2 | Recruiting | Definium Therapeutics US, Inc. | 20 | 2025-12-03 | 2026-09-02 |
| 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 |
| Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID], Placebo - Autism Spectrum Disorder | Phase 2 | Recruiting | New York State Psychiatric Institute | 30 | 2025-10-01 | 2026-09-02 |
| Investigating the Therapeutic Efficacy of All-trans Retinoic Acid in Autism Spectrum Disorder Patients With 15q11-13 Duplication Syndrome ATRA - Dup15q Syndrome, Autism Spectrum Disorder | Phase 2 | Not yet recruiting | Second Affiliated Hospital, Zhejiang University, School of Medicine | 90 | 2025-09-01 | 2025-07-23 |
| Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms FMT Protocol - Autism Spectrum Disorder, Fecal Microbiota Transplantation (FMT) | Phase 2 | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 5 | 2025-09-01 | 2025-08-05 |
| Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism hUC-MSC-Exos Nasal Spray - Autism Spectrum Disorder (ASD, Prospective Study | Phase 1 / Phase 2 | Recruiting | Dongfang People's Hospital | 60 | 2025-09-01 | 2026-10-16 |
| Treatment Planning for ABA Employing Auxiliary Tools V2+ (TREAAT2+) Tech-enabled ABA treatment planning - Autism Spectrum Disorder | Phase 1 / Phase 2 | Not yet recruiting | Montera Health Texas LLC | 20 | 2025-07-01 | 2024-11-22 |
| Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models Bumetanide, Treatment as usual (TAU) - Autism Spectrum Disorder | Phase 2 | Completed | Fei Li | 66 | 2025-06-04 | 2026-04-29 |
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Autism Spectrum Disorder (179) · Autistic Disorder (161) · Asperger Syndrome (20) · Anxiety Disorders (14) · Fragile X Syndrome (9) · Attention Deficit Disorder with Hyperactivity (6) · Aggression (5) · Communication (5) · Constipation (4) · Developmental Disabilities (4) · Diarrhea (4) · Epilepsy (4) · Intellectual Disability (4) · Rett Syndrome (4)
Mental Disorders (269) · Neurodevelopmental Disorders (268) · Autism Spectrum Disorder (91) · Nervous System Diseases (35) · Neurologic Manifestations (31) · Neurobehavioral Manifestations (26) · Pathological Conditions, Signs and Symptoms (25) · Signs and Symptoms (25) · Behavior (22) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (20) · Genetic Diseases, Inborn (19) · Heredodegenerative Disorders, Nervous System (17) · Congenital Abnormalities (14) · Genetic Diseases, X-Linked (13)
Oxytocin (13) · Leucovorin (9) · Acetylcysteine (7) · Sodium Chloride (7) · Aripiprazole (5) · Everolimus (5) · Fatty Acids, Omega-3 (5) · Memantine (5) · Therapeutics (5) · arbaclofen placarbil (5) · Buspirone (4) · Cognitive Behavioral Therapy (4) · Donepezil (4) · Risperidone (4) · Sertraline (4)
Stanford University (17) · Holland Bloorview Kids Rehabilitation Hospital (10) · University of California, San Francisco (7) · Arizona State University (5) · Assistance Publique - Hôpitaux de Paris (5) · Forest Laboratories (5) · Massachusetts General Hospital (5) · National Institute of Mental Health (NIMH) (5) · University of California, Los Angeles (5) · University of North Carolina, Chapel Hill (5) · Boston Children's Hospital (4) · Evdokia Anagnostou (4) · Southwest Autism Research & Resource Center (4) · Hoffmann-La Roche (3) · Icahn School of Medicine at Mount Sinai (3)
United States (185) · Canada (20) · France (13) · China (11) · Israel (8) · Spain (8) · Australia (7) · Italy (7) · New Zealand (4) · South Africa (4) · South Korea (4) · Vietnam (4) · Belgium (3) · Colombia (3) · Estonia (3)
Evdokia Anagnostou, M.D. (8) · Linmarie Sikich, MD (7) · Alexander Kolevzon, MD (5) · Antonio Hardan, MD (4) · Antonio Y. Hardan, MD (4) · James McCracken, MD (4) · Richard E Frye, MD, PhD (4) · James B Adams, PhD (3) · James B. Adams, PhD (3) · Jeremy Veenstra-VanderWeele, MD (3) · John Hegarty, PhD (3) · Jordan Lateiner, MS, MBA (3) · Mustafa Sahin, MD, PhD (3) · Richard P Malone, MD (3)
PMID 37811711, PMID 36006807, PMID 37460385, PMID 38114596, PMID 38363467, PMID 10341379, PMID 11918106, PMID 14733976, PMID 17109795, PMID 17352947, PMID 17520797, PMID 17671050, PMID 18315448, PMID 18555170, PMID 19148734, PMID 19186083, PMID 19309326, PMID 19398354, PMID 19487623, PMID 19491110, PMID 20145986, PMID 20406576, PMID 20620105, PMID 20683766, PMID 21643649, PMID 21883204, PMID 22151477, PMID 22342106, PMID 23097920, PMID 23106988, PMID 23216716, PMID 23357440, PMID 23688534, PMID 23782126, PMID 23978163, PMID 24061784, PMID 24356715, PMID 24472253, PMID 24839884, PMID 24849255, PMID 25187257, PMID 25313065, PMID 25526831, PMID 25685306, PMID 25798215, PMID 25818246, PMID 25878901, PMID 26746121, PMID 26889605, PMID 27752075
P50HD109861 (3), 2019 (2), 2025 (2), K99HD101702 (2), 2009 (1), 2014 (1), 2015 (1), 2017 (1), 2018 (1), 5KL2TR001109-05 (1), P50HD055784 (1), P50HD093074 (1), P50MH100023 (1), R00HD101702 (1), R01HD088528 (1)